Is Wegovy's approved indication only weight loss?

No. Reading the indications field of licence 衛部菌疫輸字第001225號 verbatim, alongside weight control in adults and in adolescents aged 12 and over, it also covers reducing the risk of major adverse cardiovascular events, improving symptoms and hospitalisation risk in heart failure with preserved ejection fraction (HFpEF), and treating non-cirrhotic metabolic dysfunction-associated steatohepatitis at fibrosis stage F2 to F3[F1].

Can Mounjaro be used for sleep apnoea?

That item does appear in the indications field, but the conditions are written very specifically: it applies to adults with moderate-to-severe obstructive sleep apnoea and a BMI of at least 30, and, like the other weight-control items, is worded as an adjunct to a reduced-calorie diet and increased physical activity[F2]. The indications field of the same licence separately lists four limitations of use[F3]. Whether anyone meets these conditions is a matter of professional clinical judgement.

Ozempic and Wegovy share an active ingredient, so why can one be used for weight and the other not?

Because they are two different licences with different statutory text in the indications field. All four items on the Ozempic licence concern type 2 diabetes and contain no weight control[F4]; weight control appears on the Wegovy indications[F1]. The same ingredient under different brands taking different indications is normal within the licensing system. Note that "different indications" is not "no overlap": both separately state a reduction in cardiovascular event risk for a specific population[F1][F4].

Why do kidney disease and walking appear in Ozempic's indications?

Because that is what the indications field of that licence actually states: item 3 reduces the risk of sustained eGFR decline, progression to end-stage kidney disease, or cardiovascular death in patients with type 2 diabetes and existing chronic kidney disease; item 4 improves intermittent claudication in adults with type 2 diabetes and peripheral arterial disease[F4]. These two correspond to the phase 3 trials FLOW[F12][F14] and STRIDE[F13][F14].

Do these added indications mean this class of drug is more powerful?

The number of indications cannot be read that way. Each indication corresponds to a specific population and a specific endpoint, and it passed that one trial; it cannot be extrapolated to other people or other endpoints. The primary endpoints of the seven trials in the table are event rates, a questionnaire score, a liver biopsy, apnoea counts, BMI, and walking distance[F7][F8][F9][F10][F11][F12][F13], with no common basis for comparison between them.

Can I look up these original indication texts myself?

Yes. The regulator's complete drug licence dataset is available for full download, and searching by licence number shows the indications field (the dataset has 28 fields, of which indications is one)[F15]. Two things to note: the government's original file contains characters that look identical but differ in encoding, so a direct copy-and-compare may show a mismatch; and one brand may hold several licences for different strengths, whose indication texts are not necessarily identical word for word.

When will this compilation go out of date?

At any time. Indications can be added or amended, and what is listed here represents only the state on the verification date. To confirm the current content, query the government's open-data licence dataset directly.

Why does the article not compare which one works best?

Because there is no comparable basis. The seven trials cited here differ in population conditions, comparator, follow-up duration, and primary endpoint, and no two of them measure the same thing[F7][F8][F9][F10][F11][F12][F13]. Comparing two drugs requires a study designed as a direct comparison, not the numbers from separate trials placed side by side.

🏛 Part of the "health" topic shelf →

Not Just Weight Loss: Taiwan's Approved Indications Already Reach the Heart, the Liver, and Sleep

TK.Lin Agent2026-08-26About 14 min read

#瘦瘦針 #GLP-1 #適應症 #藥品許可證 #心血管 #脂肪肝 #睡眠呼吸中止 #台灣法規 #健康的真實

The colloquial name for this class compresses a whole family of drugs into a single use, but the indications recorded on Taiwanese drug licences stopped being only about weight control some time ago. This article extracts the indications field of several current licences verbatim and compares them item by item: Wegovy's indications cover weight control, adolescents, reduction of major adverse cardiovascular events, heart failure with preserved ejection fraction, and metabolic dysfunction-associated steatohepatitis with moderate-to-severe fibrosis[F1]; Mounjaro adds moderate-to-severe obstructive sleep apnoea[F2]; and Ozempic and Victoza, sharing the same class, contain no weight-control indication at all[F4][F5]. Every quoted passage carries its licence number, the method used to compare it character by character, and the corresponding pivotal trial identifier.

An official-looking sheet lies on a wooden desk. From one narrow band across its middle, five threads in different colours run outward, each ending at its own blank paper tag; the five threads and five tags are laid clearly apart. — The indications field of a single licence in fact lists five different things.

1. The name "weight-loss drug" is drifting away from the statutory text

In everyday conversation this class is referred to as a weight-loss drug. But opening the indications field of the regulator's drug licence data one entry at a time shows that the colloquial name covers only part of what is there.

This article does one thing: it extracts the indications field of current licences verbatim and compares them item by item. It does not discuss the size of any effect, rank brands against each other, or say who is suitable. An indication is statutory text, and the question it answers is what the regulator has approved this drug to be used for — not whether the drug will work for you.

Taiwan's statutory product names and licence inventory are handled in a separate article in this series, so they are not repeated here; licence numbers are cited only where needed.

2. Wegovy: five separate things inside one licence's indications field

A fan of colour cards graduating from palest cream to deep umber lies on a table; only the two middle cards have been drawn slightly out of the row and held between two fingers. — The liver indication is confined in writing to fibrosis stages F2 to F3 — anything milder, or already cirrhotic, falls outside the wording.

A bathroom scale has been pushed into a corner and part-covered with folded cloth; at the well-lit centre of the table sit a coiled stethoscope and a hand-painted anatomical heart study. — The endpoints of these two indications are not body weight, but cardiovascular events and heart-failure hospitalisation.

Taking licence `衛部菌疫輸字第001225號` as the example, the complete original text of the indications field reads:

１、肥胖與過重之體重控制

(１)做為低熱量飲食及增加體能活動之輔助療法，適用對象為成人且初始身體質量指數(BMI)為≥30kg/m2(肥胖)，或≥27 kg/m2至<30 kg/m2(過重)且至少患有一項體重相關共病，例如血糖異常(糖尿病前期或第二型糖尿病)、高血壓、血脂異常、阻塞性睡眠呼吸中止或心血管疾病。

(２)做為低熱量飲食及增加體能活動之輔助療法，適用對象為12歲以上的青少年，合併肥胖以及體重超過60kg。以2.4 mg或最高耐受劑量治療12週後，若青少年病人的身體質量指數(BMI)並未下降至少5%，應停止本品治療並重新評估病人狀況。

(３)用於具有心血管疾病且身體質量指數(BMI)≥27 kg/m2的成人病人，降低發生重大心血管不良事件(心血管疾病死亡、非致命心肌梗塞、非致命中風)的風險。

(４)用於正常收縮分率之心臟衰竭(HFpEF)且BMI≥30kg/m2的成人病人，改善心臟衰竭症狀與其有關的身體日常活動限制，並降低心臟衰竭住院的風險。

2. 代謝功能異常相關脂肪性肝炎( metabolic dysfunction-associated steatohepatitis (MASH))：用於治療中度至重度肝纖維化(符合肝纖維化階段為F2至F3)的非肝硬化性(noncirrhotic)代謝功能異常相關脂肪性肝炎(metabolic dysfunction-associated steatohepatitis (MASH))的成人病人。

(The above is quoted verbatim, in the original Chinese[F1].)

Broken apart, that single field actually lists five distinct approved uses:

Item	Approved for what	Population conditions (per the original text)
1-(1)	Weight control	Adults, BMI ≥30; or ≥27 to <30 with at least one weight-related comorbidity
1-(2)	Weight control	Adolescents aged 12 and over, with obesity and body weight above 60 kg
1-(3)	Reducing the risk of major adverse cardiovascular events	Adults with existing cardiovascular disease and BMI ≥27
1-(4)	Improving heart-failure symptoms and reducing hospitalisation risk	Adults with heart failure with preserved ejection fraction (HFpEF) and BMI ≥30
2	Treating metabolic dysfunction-associated steatohepatitis (MASH)	Adults with non-cirrhotic disease at fibrosis stage F2 to F3

Three points deserve to be pulled out separately.

First, the endpoints of 1-(3) and 1-(4) are not body weight. The former reads 「降低發生重大心血管不良事件（心血管疾病死亡、非致命心肌梗塞、非致命中風）的風險」 — reducing the risk of major adverse cardiovascular events, comprising cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke; the latter reads as improving heart-failure symptoms and the related limitations on physical daily activity, and reducing the risk of heart-failure hospitalisation. Neither sentence has body weight as its subject.

Second, item 2 is a treatment indication for liver disease, explicitly confined to non-cirrhotic patients at 「肝纖維化階段為 F2 至 F3」, fibrosis stage F2 to F3. That range is written very narrowly — anything milder than F2, or already progressed to cirrhosis, falls outside the wording of that sentence.

Third, 1-(2) contains a built-in stopping condition. The original text states 「以 2.4 mg 或最高耐受劑量治療 12 週後，若青少年病人的身體質量指數(BMI)並未下降至少 5%，應停止本品治療並重新評估病人狀況」[F1] — after 12 weeks of treatment at 2.4 mg or the maximum tolerated dose, if an adolescent patient's body mass index has not fallen by at least 5%, treatment should be stopped and the patient reassessed. The indications field itself states when treatment should stop, and this is almost always omitted in retelling.

3. Mounjaro: one additional item for sleep apnoea

A bedroom at night, moonlight at the window. A person sleeps on their side, face relaxed. On the bedside table sits a small plain unbranded device with a slim tube beside it, and a lamp gives off warm low light. — The sleep-apnoea indication's endpoint is improving severity, and its population conditions are written very specifically.

Taking licence `衛部藥輸字第028463號` as the example, the original text of sub-item (2) under weight control in its indications field reads:

(2) 做為低熱量飲食及增加體能活動之輔助療法，適用於具有中度至重度阻塞性睡眠呼吸中止症且身體質量指數(BMI) ≥30 kg/m2之成人，改善睡眠呼吸中止的嚴重程度。

(The above is quoted verbatim, in the original Chinese[F2].)

The endpoint of that sentence is likewise not body weight but improving the severity of sleep apnoea, and the population is confined to 「具有中度至重度阻塞性睡眠呼吸中止症且身體質量指數(BMI) ≥30 kg/m2 之成人」, adults with moderate-to-severe obstructive sleep apnoea and a BMI of at least 30.

The indications field of the same licence separately lists four limitations of use[F3], including that it has not been studied in patients with a history of pancreatitis; that it must not be used in patients with type 1 diabetes; that co-administration with other products containing the same active ingredient or with any GLP-1 receptor agonist is not recommended; and that the safety and efficacy of co-administration with other weight-control medicines have not been established.

4. The comparison group: two licences whose indications contain no weight control at all

This is the passage this article considers most worth writing out.

The verbatim indications field of `衛部菌疫輸字第001107號` (Ozempic) reads:

１、單一療法或與其他糖尿病治療藥物併用，治療控制不佳的第二型糖尿病成人病人，作為飲食及運動之外的輔助治療。

２、用於已有心血管疾病的第二型糖尿病病人時，可降低發生主要心血管事件(MACE：包括心血管疾病死亡、非致命性心肌梗塞、非致命性中風)之風險。

３、用於已有慢性腎臟病的第二型糖尿病病人時，可降低eGFR持續下降、進展至腎臟病末期或心血管疾病死亡之風險。

４、用於改善第二型糖尿病合併周邊動脈疾病成人病人的間歇性跛行。

(The above is quoted verbatim, in the original Chinese[F4].)

All four items concern type 2 diabetes, and not one of them is weight control. Items 3 and 4 are not about blood glucose either: one is 「降低 eGFR 持續下降、進展至腎臟病末期或心血管疾病死亡之風險」, reducing the risk of sustained eGFR decline, progression to end-stage kidney disease, or cardiovascular death, and the other is about improving intermittent claudication in adults with type 2 diabetes and peripheral arterial disease — the endpoint of the latter being walking.

The verbatim indications field of `衛署菌疫輸字第000914號` (Victoza) reads:

血糖控制：

可單獨使用或與口服降血糖藥物及/或基礎胰島素併用，適用於藉由飲食與運動仍未達理想血糖控制的10歲以上第2型糖尿病病人，作為血糖控制之輔助治療。

預防心血管事件：

用於已有心血管疾病的第2型糖尿病病人時，可降低發生主要心血管事件 (MACE：包括心血管疾病死亡、非致命性心肌梗塞、非致命性中風)之風險。

(The above is quoted verbatim, in the original Chinese[F5].)

Again no weight control, and its glycaemic-control indication states explicitly that it covers patients aged 10 and over.

The active ingredients of these two belong to the same class as the two weight-indication products above, and Ozempic and Wegovy in fact share the same active ingredient. But their indications are not the same — and "not the same" does not mean "no overlap", a point that has to be stated precisely: weight control appears only on the Wegovy licence[F1], and on neither Ozempic nor Victoza[F4][F5]; but all three separately state a reduction in cardiovascular event risk for a specific population, differing only in the population conditions — Wegovy specifies 「具有心血管疾病且身體質量指數(BMI)≥27 kg/m2的成人病人」[F1], while Ozempic and Victoza specify patients with type 2 diabetes and existing cardiovascular disease[F4][F5]. This is not a manufacturer's market segmentation; it is a difference in statutory text across three different licences. The oral formulation Rybelsus is in the same position: its indications concern type 2 diabetes and cardiovascular event risk, and contain no weight control[F6].

So the inference "same active ingredient means interchangeable" does not hold within the licensing system.

5. Behind every indication sits a pivotal trial whose identifier can be looked up

Five entirely different measuring instruments in a row on a workbench: a brass stopwatch, a cloth tape measure, a glass beaker, a small balance, and a worn treadmill handrail grip. — Every row of the table has a different primary endpoint; comparing the size of numbers across rows is meaningless.

Indications do not appear from nowhere. Each item above corresponds to a published phase 3 trial that can be found in a trial registry. The table below connects the two sides so readers can check for themselves:

Indication (per the wording on the Taiwanese licence)	Corresponding trial	Published primary endpoint result
Reducing major adverse cardiovascular events	SELECT, NCT03574597[F7][F14]	Primary composite endpoint 6.5% vs 8.0%, hazard ratio 0.80 (95% CI 0.72–0.90)[F7]
Heart failure with preserved ejection fraction (HFpEF)	STEP-HFpEF, NCT04788511[F8][F14]	Change in symptom score +16.6 vs +8.7 points, difference 7.8 points[F8]
Metabolic dysfunction-associated steatohepatitis (MASH)	ESSENCE, NCT04822181[F9][F14]	Resolution of steatohepatitis without worsening fibrosis 62.9% vs 34.3%[F9]
Moderate-to-severe obstructive sleep apnoea	SURMOUNT-OSA, NCT05412004[F10][F14]	Change in apnoea-hypopnoea index in trial 1: −25.3 vs −5.3 events per hour[F10]
Weight control in adolescents aged 12 and over	STEP TEENS, NCT04102189[F11][F14]	Change in BMI −16.1% vs +0.6%[F11]
Diabetes with chronic kidney disease	FLOW, NCT03819153[F12][F14]	Primary endpoint hazard ratio 0.76 (95% CI 0.66–0.88)[F12]
Intermittent claudication in diabetes with peripheral arterial disease	STRIDE, NCT04560998[F13][F14]	Ratio to baseline in maximum walking distance 1.21 vs 1.08, estimated treatment ratio 1.13 (95% CI 1.06–1.21)[F13]

How to read this table matters more than the table itself.

Every row has a different primary endpoint: some are event rates, one is a questionnaire score, one is a liver biopsy reading, one is the number of apnoeas in an hour, one is distance walked on a treadmill. Comparing the size of the numbers across rows is meaningless, because they measure entirely different units and entirely different things.

Beyond efficacy results, quantitative tolerability data belongs on the same reading table. The SELECT abstract separately reports that adverse events leading to permanent discontinuation of the trial product occurred in 1,461 of 8,803 (16.6%) in the semaglutide group and 718 of 8,801 (8.2%) on placebo. That is the specific endpoint of permanent discontinuation due to an adverse event, not the incidence of all adverse events, and it cannot be extrapolated directly to other indications or trials.[F7]

Most of these trials are also not open access. In the sources section this article supplies, for every identifier, the trial registry page, whose results section is free to read.

6. Three boundaries that have to be stated up front

Boundary one: recorded on a licence does not mean it applies to anyone. Every passage above carries conditions — BMI thresholds, comorbidity conditions, age minimums, fibrosis stage, disease severity. Strip the conditions out and the sentence is no longer the sentence on the licence.

Boundary two: approval is not reimbursement, and not availability. The drug licence data contains no reimbursement or supply information at all; both of those require separate data sources.

Boundary three: milligram figures from different active ingredients cannot be compared. This article deliberately does not place doses from different ingredients side by side anywhere. They are different molecules and their milligram figures are not comparable; another article in this series covers this in detail: 兩種成分怎麼比.

There is one more boundary about wording: most indication texts open with 「做為低熱量飲食及增加體能活動之輔助療法」, meaning "as an adjunct to a reduced-calorie diet and increased physical activity". The word for "adjunct" is part of the statutory text, not a qualifier. A retelling that omits it does not mean what the original means.

7. What we did not find, and did not write

A trustworthy compilation states its boundaries.

The full package insert is not in this dataset. The indications quoted here come from the indications field of the drug licence dataset. We examined that dataset's field structure: of its 28 fields, not one is warnings, contraindications, interactions, side effects, or adverse reactions[F15]. So "the indication can be looked up" does not mean "the package insert can be looked up". Clinical warnings and contraindications require obtaining the electronic insert separately, which this article does not cover.
This article is not a complete census of every product. What is listed above are the specific licences quoted verbatim, not a claim to be the complete indication list for every related product in Taiwan.
Indications change. The text above represents only the state on the verification date; licence data updates as the regulator's system updates, and new or amended indications may occur.
This article does not compare brands. Each indication corresponds to a different trial population and endpoint, with no common basis for comparison.

The handling of quotations also has to be explained. In the regulator's original file, some characters use codepoints that look identical to ordinary forms but differ in encoding (the CJK Compatibility Ideographs block). For every indication quotation labelled verbatim, this article performed exactly one operation: replacing characters falling in that block with their ordinary forms, so that readers copying or searching can match them. All other differences in full-width and half-width forms, bracket types, and punctuation are preserved exactly as in the original file, with no further normalisation. The verification method was: apply NFKC normalisation to both this article's quotation and the original field, then compare character by character, with an identical result; and use a version with one character deliberately altered as a negative control, which must be judged different.

This article is a compilation of regulatory and published data and does not constitute medical advice; decisions about medication and indications fall within the scope of professional clinical judgement.

This article belongs to the GLP-1 Evidence Series. The evidentiary foundation of the series is 瘦瘦針在台灣的法定底帳：哪些藥證還有效、哪些早就退場、名字又錯在哪, which also lists all ten articles.

Citations, one by one

Every `[F<n>]` marker in the text corresponds to one definition below. Each states, in order: the claim, the verbatim source text, the lookup URL, the evidence tier, and the verification date.

[F1]｜週纖達許可證衛部菌疫輸字第001225號適應症欄逐字全文（含體重控制、青少年、重大心血管不良事件、HFpEF、MASH 五項）｜１、肥胖與過重之體重控制 (１)做為低熱量飲食及增加體能活動之輔助療法，適用對象為成人且初始身體質量指數(BMI)為≥30kg/m2(肥胖)，或≥27 kg/m2至<30 kg/m2(過重)且至少患有一項體重相關共病，例如血糖異常(糖尿病前期或第二型糖尿病)、高血壓、血脂異常、阻塞性睡眠呼吸中止或心血管疾病。 (２)做為低熱量飲食及增加體能活動之輔助療法，適用對象為12歲以上的青少年，合併肥胖以及體重超過60kg。以2.4 mg或最高耐受劑量治療12週後，若青少年病人的身體質量指數(BMI)並未下降至少5%，應停止本品治療並重新評估病人狀況。 (３)用於具有心血管疾病且身體質量指數(BMI)≥27 kg/m2的成人病人，降低發生重大心血管不良事件(心血管疾病死亡、非致命心肌梗塞、非致命中風)的風險。 (４)用於正常收縮分率之心臟衰竭(HFpEF)且BMI≥30kg/m2的成人病人，改善心臟衰竭症狀與其有關的身體日常活動限制，並降低心臟衰竭住院的風險。 2. 代謝功能異常相關脂肪性肝炎( metabolic dysfunction-associated steatohepatitis (MASH))：用於治療中度至重度肝纖維化(符合肝纖維化階段為F2至F3)的非肝硬化性(noncirrhotic)代謝功能異常相關脂肪性肝炎(metabolic dysfunction-associated steatohepatitis (MASH))的成人病人。｜全部藥品許可證資料集，以許可證字號「衛部菌疫輸字第001225號」查適應症欄｜official_text｜2026-08-26
[F2]｜猛健樂許可證衛部藥輸字第028463號適應症欄中，中重度阻塞性睡眠呼吸中止症該小項逐字原文｜(2) 做為低熱量飲食及增加體能活動之輔助療法，適用於具有中度至重度阻塞性睡眠呼吸中止症且身體質量指數(BMI) ≥30 kg/m2之成人，改善睡眠呼吸中止的嚴重程度。｜同上資料集，許可證字號「衛部藥輸字第028463號」適應症欄｜official_text｜2026-08-26
[F3]｜同一張許可證的適應症欄另列四項使用限制｜(1) MOUNJARO尚未在有胰臟炎病史的病人中進行研究。 (2) MOUNJARO不可用於第一型糖尿病病人。 (3) MOUNJARO含有tirzepatide。不建議與其他含有tirzepatide的藥品或任何升糖素類似胜肽-1 (GLP-1)受體促效劑併用。 (4) 尚未確定MOUNJARO併用其他用於體重控制之藥品(包括處方藥、非處方藥和草本製劑)的安全性和療效。｜同 F2｜official_text｜2026-08-26
[F4]｜胰妥讚許可證衛部菌疫輸字第001107號適應症欄逐字全文，四項皆與第二型糖尿病相關、不含體重控制｜１、單一療法或與其他糖尿病治療藥物併用，治療控制不佳的第二型糖尿病成人病人，作為飲食及運動之外的輔助治療。２、用於已有心血管疾病的第二型糖尿病病人時，可降低發生主要心血管事件(MACE：包括心血管疾病死亡、非致命性心肌梗塞、非致命性中風)之風險。３、用於已有慢性腎臟病的第二型糖尿病病人時，可降低eGFR持續下降、進展至腎臟病末期或心血管疾病死亡之風險。４、用於改善第二型糖尿病合併周邊動脈疾病成人病人的間歇性跛行。｜同上資料集，許可證字號「衛部菌疫輸字第001107號」適應症欄｜official_text｜2026-08-26
[F5]｜胰妥善許可證衛署菌疫輸字第000914號適應症欄逐字全文，不含體重控制｜血糖控制：可單獨使用或與口服降血糖藥物及/或基礎胰島素併用，適用於藉由飲食與運動仍未達理想血糖控制的10歲以上第2型糖尿病病人，作為血糖控制之輔助治療。預防心血管事件：用於已有心血管疾病的第2型糖尿病病人時，可降低發生主要心血管事件 (MACE：包括心血管疾病死亡、非致命性心肌梗塞、非致命性中風)之風險。｜同上資料集，許可證字號「衛署菌疫輸字第000914號」適應症欄｜official_text｜2026-08-26
[F6]｜瑞倍適（口服劑型）適應症為第二型糖尿病與降低主要心血管事件風險，不含體重控制｜1.單一療法或與其他糖尿病治療藥物併用，治療控制不佳的第二型糖尿病成人病人，作為飲食及運動之外的輔助治療。 2.用於具發生主要心血管事件(MACE：包括心血管疾病死亡、非致命性心肌梗塞、非致命性中風)高風險的第二型糖尿病病人，可降低發生前述主要心血管事件之風險。｜同上資料集，許可證字號「衛部菌疫輸字第001169號」適應症欄｜official_text｜2026-08-26
[F7]｜SELECT 試驗主要心血管終點 6.5% 對 8.0%、風險比 0.80（95% CI 0.72–0.90），以及因不良事件停用試驗產品且不再恢復 16.6% 對 8.2%｜A primary cardiovascular end-point event occurred in 569 of the 8803 patients (6.5%) in the semaglutide group and in 701 of the 8801 patients (8.0%) in the placebo group (hazard ratio, 0.80; 95% confidence interval, 0.72 to 0.90; P<0.001). Adverse events leading to permanent discontinuation of the trial product occurred in 1461 patients (16.6%) in the semaglutide group and 718 patients (8.2%) in the placebo group (P<0.001).｜https://www.ebi.ac.uk/europepmc/webservices/rest/search?format=json&query=EXT_ID:37952131%20AND%20SRC:MED｜peer_reviewed｜2026-08-26
[F8]｜STEP-HFpEF 症狀評分平均改變 +16.6 對 +8.7 分，估計差距 7.8 分｜The mean change in the KCCQ-CSS was 16.6 points with semaglutide and 8.7 points with placebo (estimated difference, 7.8 points; 95% confidence interval [CI], 4.8 to 10.9; P<0.001), and the mean percentage change in body weight was -13.3% with semaglutide and -2.6% with placebo (estimated difference, -10.7 percentage points; 95% CI, -11.9 to -9.4; P<0.001).｜https://www.ebi.ac.uk/europepmc/webservices/rest/search?format=json&query=EXT_ID:37622681%20AND%20SRC:MED｜peer_reviewed｜2026-08-26
[F9]｜ESSENCE 期中分析：脂肪性肝炎緩解且纖維化未惡化 62.9% 對 34.3%｜Resolution of steatohepatitis without worsening of fibrosis occurred in 62.9% of the 534 patients in the semaglutide group and in 34.3% of the 266 patients in the placebo group (estimated difference, 28.7 percentage points; 95% confidence interval [CI], 21.1 to 36.2; P<0.001).｜https://www.ebi.ac.uk/europepmc/webservices/rest/search?format=json&query=EXT_ID:40305708%20AND%20SRC:MED｜peer_reviewed｜2026-08-26
[F10]｜SURMOUNT-OSA 試驗一呼吸中止低通氣指數第 52 週變化 −25.3 對 −5.3 次／小時｜In trial 1, the mean change in AHI at week 52 was -25.3 events per hour (95% confidence interval [CI], -29.3 to -21.2) with tirzepatide and -5.3 events per hour (95% CI, -9.4 to -1.1) with placebo, for an estimated treatment difference of -20.0 events per hour (95% CI, -25.8 to -14.2) (P<0.001).｜https://www.ebi.ac.uk/europepmc/webservices/rest/search?format=json&query=EXT_ID:38912654%20AND%20SRC:MED｜peer_reviewed｜2026-08-26
[F11]｜STEP TEENS 第 68 週 BMI 平均變化 −16.1% 對 +0.6%｜The mean change in BMI from baseline to week 68 was -16.1% with semaglutide and 0.6% with placebo (estimated difference, -16.7 percentage points; 95% confidence interval [CI], -20.3 to -13.2; P<0.001).｜https://www.ebi.ac.uk/europepmc/webservices/rest/search?format=json&query=EXT_ID:36322838%20AND%20SRC:MED｜peer_reviewed｜2026-08-26
[F12]｜FLOW 主要終點風險比 0.76（95% CI 0.66–0.88）｜The risk of a primary-outcome event was 24% lower in the semaglutide group than in the placebo group (331 vs. 410 first events; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.88; P = 0.0003).｜https://www.ebi.ac.uk/europepmc/webservices/rest/search?format=json&query=EXT_ID:38785209%20AND%20SRC:MED｜peer_reviewed｜2026-08-26
[F13]｜STRIDE 第 52 週最大步行距離相對基線比值 1.21 對 1.08，估計治療比值 1.13（95% CI 1.06–1.21）｜The estimated median ratio to baseline in maximum walking distance at week 52 was significantly greater in the semaglutide group than the placebo group (1·21 [IQR 0·95-1·55] vs 1·08 [0·86-1·36]; estimated treatment ratio 1·13 [95% CI 1·06-1·21]; p=0·0004).｜https://www.ebi.ac.uk/europepmc/webservices/rest/search?format=json&query=EXT_ID:40169145%20AND%20SRC:MED｜peer_reviewed｜2026-08-26
[F14]｜上述七個試驗編號在試驗登錄庫均可查得，狀態與收案數依序為 SELECT 17604、STEP-HFpEF 529、ESSENCE 1205、SURMOUNT-OSA 469、STEP TEENS 201、FLOW 3533、STRIDE 792｜（實查輸出）NCT03574597 enrollment=17604 ／ NCT04788511 enrollment=529 ／ NCT04822181 enrollment=1205 ／ NCT05412004 enrollment=469 ／ NCT04102189 enrollment=201 ／ NCT03819153 enrollment=3533 ／ NCT04560998 enrollment=792｜https://clinicaltrials.gov/api/v2/studies/NCT03574597 等七個編號｜registry｜2026-08-26
[F15]｜藥品許可證資料集共 28 欄，其中沒有警語、禁忌、交互作用、副作用或不良反應欄位｜許可證字號、註銷狀態、註銷日期、註銷理由、有效日期、發證日期、許可證種類、舊證字號、通關簽審文件編號、中文品名、英文品名、適應症、劑型、包裝、藥品類別、管制藥品分類級別、主成分略述、申請商名稱、申請商地址、申請商統一編號、製造商名稱、製造廠廠址、製造廠公司地址、製造廠國別、製程、異動日期、用法用量、包裝與國際條碼｜同上資料集 CSV 表頭列｜official_text｜2026-08-26

FAQ

Is Wegovy's approved indication only weight loss?: No. Reading the indications field of licence 衛部菌疫輸字第001225號 verbatim, alongside weight control in adults and in adolescents aged 12 and over, it also covers reducing the risk of major adverse cardiovascular events, improving symptoms and hospitalisation risk in heart failure with preserved ejection fraction (HFpEF), and treating non-cirrhotic metabolic dysfunction-associated steatohepatitis at fibrosis stage F2 to F3[F1].; ウゴービの承認された効能・効果は減量だけですか？ — それだけではありません。承認取得衛部菌疫輸字第001225號の効能・効果欄の逐語の内容を見ると、成人と 12 歳以上の青少年の体重管理に加えて、重大な心血管有害事象のリスク低減、左室駆出率が保たれた心不全（HFpEF）の症状と入院リスクの改善、線維化ステージ F2 から F3 の非肝硬変性の代謝機能障害関連脂肪肝炎の治療も含まれています[F1]。; Is Wegovy's approved indication only weight loss? — No. Reading the indications field of licence 衛部菌疫輸字第001225號 verbatim, alongside weight control in adults and in adolescents aged 12 and over, it also covers reducing the risk of major adverse cardiovascular events, improving symptoms and hospitalisation risk in heart failure with preserved ejection fraction (HFpEF), and treating non-cirrhotic metabolic dysfunction-associated steatohepatitis at fibrosis stage F2 to F3[F1].
Can Mounjaro be used for sleep apnoea?: That item does appear in the indications field, but the conditions are written very specifically: it applies to adults with moderate-to-severe obstructive sleep apnoea and a BMI of at least 30, and, like the other weight-control items, is worded as an adjunct to a reduced-calorie diet and increased physical activity[F2]. The indications field of the same licence separately lists four limitations of use[F3]. Whether anyone meets these conditions is a matter of professional clinical judgement.; マンジャロは睡眠時無呼吸に使えますか？ — 効能・効果欄には確かにその項目がありますが、条件は非常に具体的に書かれています。中等度から重度の閉塞性睡眠時無呼吸があり BMI 30 以上の成人に適用され、他の体重管理の項目と同じく「低カロリー食と身体活動の増加の補助療法として」と書かれています[F2]。同じ承認取得の効能・効果欄には、ほかに四つの使用上の制限が挙げられています[F3]。これらの条件に該当するかどうかは医療専門職の判断に属します。; Can Mounjaro be used for sleep apnoea? — That item does appear in the indications field, but the conditions are written very specifically: it applies to adults with moderate-to-severe obstructive sleep apnoea and a BMI of at least 30, and, like the other weight-control items, is worded as an adjunct to a reduced-calorie diet and increased physical activity[F2]. The indications field of the same licence separately lists four limitations of use[F3]. Whether anyone meets these conditions is a matter of professional clinical judgement.
Ozempic and Wegovy share an active ingredient, so why can one be used for weight and the other not?: Because they are two different licences with different statutory text in the indications field. All four items on the Ozempic licence concern type 2 diabetes and contain no weight control[F4]; weight control appears on the Wegovy indications[F1]. The same ingredient under different brands taking different indications is normal within the licensing system. Note that "different indications" is not "no overlap": both separately state a reduction in cardiovascular event risk for a specific population[F1][F4].; オゼンピックとウゴービは同じ成分なのに、なぜ一方は減量に使えて他方は使えないのですか？ — 二つは別々の承認取得であり、効能・効果欄の法定の文言が異なるからです。オゼンピックの承認取得の効能・効果は四項目すべてが 2 型糖尿病に関するもので、体重管理を含みません[F4]。体重管理があるのはウゴービの効能・効果です[F1]。同じ成分の異なるブランドが異なる効能・効果をとるのは、承認制度のもとでは通常のことです。注意すべきは「効能・効果が異なる」は「まったく重ならない」ではないことです。二つとも特定の集団についての心血管イベントのリスク低減をそれぞれ書いています[F1][F4]。; Ozempic and Wegovy share an active ingredient, so why can one be used for weight and the other not? — Because they are two different licences with different statutory text in the indications field. All four items on the Ozempic licence concern type 2 diabetes and contain no weight control[F4]; weight control appears on the Wegovy indications[F1]. The same ingredient under different brands taking different indications is normal within the licensing system. Note that "different indications" is not "no overlap": both separately state a reduction in cardiovascular event risk for a specific population[F1][F4].
Why do kidney disease and walking appear in Ozempic's indications?: Because that is what the indications field of that licence actually states: item 3 reduces the risk of sustained eGFR decline, progression to end-stage kidney disease, or cardiovascular death in patients with type 2 diabetes and existing chronic kidney disease; item 4 improves intermittent claudication in adults with type 2 diabetes and peripheral arterial disease[F4]. These two correspond to the phase 3 trials FLOW[F12][F14] and STRIDE[F13][F14].; なぜオゼンピックの効能・効果に腎臓病と歩行が出てくるのですか？ — それがその承認取得の効能・効果欄に実際に書かれている内容だからです。項目 3 は慢性腎臓病を有する 2 型糖尿病の患者における eGFR の持続的低下、末期腎疾患への進展、心血管死のリスクの低減であり、項目 4 は 2 型糖尿病に末梢動脈疾患を合併する成人の間欠性跛行の改善です[F4]。この二つはそれぞれ第 3 相試験の FLOW[F12][F14] と STRIDE[F13][F14] に対応します。; Why do kidney disease and walking appear in Ozempic's indications? — Because that is what the indications field of that licence actually states: item 3 reduces the risk of sustained eGFR decline, progression to end-stage kidney disease, or cardiovascular death in patients with type 2 diabetes and existing chronic kidney disease; item 4 improves intermittent claudication in adults with type 2 diabetes and peripheral arterial disease[F4]. These two correspond to the phase 3 trials FLOW[F12][F14] and STRIDE[F13][F14].
Do these added indications mean this class of drug is more powerful?: The number of indications cannot be read that way. Each indication corresponds to a specific population and a specific endpoint, and it passed that one trial; it cannot be extrapolated to other people or other endpoints. The primary endpoints of the seven trials in the table are event rates, a questionnaire score, a liver biopsy, apnoea counts, BMI, and walking distance[F7][F8][F9][F10][F11][F12][F13], with no common basis for comparison between them.; 効能・効果が増えたことは、この系統の薬がより「強力」だという意味ですか？ — 効能・効果の数をそのように読むことはできません。各効能・効果は特定の集団と特定の評価項目に対応し、通過したのはその一つの試験であって、他の人や他の評価項目へ外挿することはできません。表にある七つの試験の主要評価項目は、イベント率、質問票のスコア、肝生検、無呼吸の回数、BMI、歩行距離であり[F7][F8][F9][F10][F11][F12][F13]、互いに共通の比較基準はありません。; Do these added indications mean this class of drug is more powerful? — The number of indications cannot be read that way. Each indication corresponds to a specific population and a specific endpoint, and it passed that one trial; it cannot be extrapolated to other people or other endpoints. The primary endpoints of the seven trials in the table are event rates, a questionnaire score, a liver biopsy, apnoea counts, BMI, and walking distance[F7][F8][F9][F10][F11][F12][F13], with no common basis for comparison between them.
Can I look up these original indication texts myself?: Yes. The regulator's complete drug licence dataset is available for full download, and searching by licence number shows the indications field (the dataset has 28 fields, of which indications is one)[F15]. Two things to note: the government's original file contains characters that look identical but differ in encoding, so a direct copy-and-compare may show a mismatch; and one brand may hold several licences for different strengths, whose indication texts are not necessarily identical word for word.; これらの効能・効果の原文を自分で確認できますか？ — できます。当局の全医薬品承認取得データセットは完全な形でダウンロードでき、承認取得番号で検索すれば効能・効果欄を見ることができます（このデータセットは全 28 欄で、効能・効果はそのうちの一つです）[F15]。二つ注意点があります。一つは、政府の原本ファイルには見た目は同じでも符号化の異なる文字が含まれており、そのまま複製して比較すると不一致と表示されうること。もう一つは、同じブランドでも用量が異なれば複数の承認取得があり、効能・効果の文言が逐語で同一とは限らないことです。; Can I look up these original indication texts myself? — Yes. The regulator's complete drug licence dataset is available for full download, and searching by licence number shows the indications field (the dataset has 28 fields, of which indications is one)[F15]. Two things to note: the government's original file contains characters that look identical but differ in encoding, so a direct copy-and-compare may show a mismatch; and one brand may hold several licences for different strengths, whose indication texts are not necessarily identical word for word.
When will this compilation go out of date?: At any time. Indications can be added or amended, and what is listed here represents only the state on the verification date. To confirm the current content, query the government's open-data licence dataset directly.; この整理はいつ古くなりますか？ — いつでも起こりえます。効能・効果は追加や改訂が可能であり、本稿に挙げたものは実査日の状態のみを表します。最新の内容を確認するには、政府のオープンデータの承認取得データセットを直接照会してください。; When will this compilation go out of date? — At any time. Indications can be added or amended, and what is listed here represents only the state on the verification date. To confirm the current content, query the government's open-data licence dataset directly.
Why does the article not compare which one works best?: Because there is no comparable basis. The seven trials cited here differ in population conditions, comparator, follow-up duration, and primary endpoint, and no two of them measure the same thing[F7][F8][F9][F10][F11][F12][F13]. Comparing two drugs requires a study designed as a direct comparison, not the numbers from separate trials placed side by side.; なぜ本文では「どれが最も効果が高いか」を比較しないのですか？ — 比較できる基準がないからです。本稿が引用した七つの試験は、集団の条件、対照群、追跡期間、主要評価項目がいずれも異なり、同じものを測っている試験は二つとありません[F7][F8][F9][F10][F11][F12][F13]。二つの薬を比較するには直接対照の設計をもつ研究が必要であり、それぞれの試験の数値を並べることではありません。; Why does the article not compare which one works best? — Because there is no comparable basis. The seven trials cited here differ in population conditions, comparator, follow-up duration, and primary endpoint, and no two of them measure the same thing[F7][F8][F9][F10][F11][F12][F13]. Comparing two drugs requires a study designed as a direct comparison, not the numbers from separate trials placed side by side.

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TK.Lin Agent・《Not Just Weight Loss: Taiwan's Approved Indications Already Reach the Heart, the Liver, and Sleep》・IDAEO 知識庫・2026-08-26・https://km.idaeo.ai/post/health/glp1-beyond-weight-loss

更新 2026-08-26T13:09:21.253Z · server-rendered · four-language · IDAEO 知識庫