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FDA-approved medicines exist for specific indications

Semaglutide

GLP-1 receptor agonist peptide medicine.

Editorial review: August 13, 2026
What evidence says

Evidence snapshot

This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report: these people, this product, this endpoint. It is not a protocol. Grades name the object. They are not a safety rating.

Approved-indication papers below are about specific labeled product–use pairs. They do not travel to another product, another preparation, or another use.

Bottom line

Injectable semaglutide has large, labeled human trials for weight in adults with overweight or obesity, and for cardiovascular outcomes in the populations those trials enrolled. That is not a claim about oral obesity product, an unapproved combination, walking in peripheral artery disease, or a vial that is not the trial product. Mark the paper. Not the peptide.

Papers

Approved indication

PMID 33567185 — STEP 1

Tested: once-weekly injectable semaglutide versus placebo for body weight in adults with overweight or obesity, without diabetes.

Does not show: an effect of a different product, a different use, or a compounded or similarly named preparation.

PMID 35015037 — STEP 8

Tested: once-weekly injectable semaglutide versus daily liraglutide for body weight in adults with overweight or obesity, without diabetes.

Does not show: that every GLP-1 agonist is interchangeable, or that the result applies outside this comparison.

PMID 38330988 — STEP 7

Tested: once-weekly injectable semaglutide versus placebo for weight in a predominantly East Asian population with overweight or obesity, with or without type 2 diabetes.

Does not show: that a different region, product, or unlabeled use is settled by this trial.

PMID 37952131 — SELECT

Tested: once-weekly injectable semaglutide versus placebo for major adverse cardiovascular events in adults with overweight or obesity and preexisting cardiovascular disease, without diabetes.

Does not show: cardiovascular effect in people who do not match this enrollment, or in a different semaglutide product.

PMID 27633186 — SUSTAIN-6

Tested: once-weekly injectable semaglutide versus placebo for cardiovascular outcomes in type 2 diabetes.

Does not show: an obesity-without-diabetes claim (that is SELECT), or an oral-product claim (that is a different object).

PMID 40305708 — ESSENCE Part 1

Tested: once-weekly injectable semaglutide versus placebo for histologic MASH endpoints (resolution of steatohepatitis without worsening fibrosis; fibrosis improvement without worsening steatohepatitis) in biopsy-defined MASH with fibrosis stage 2 or 3. Interim Part 1 at week 72.

Does not show: a result for a different liver population, a different product, or Part 2 outcomes that this paper does not report.

PMID 40162642 — SOUL

Tested: once-daily oral semaglutide versus placebo for major adverse cardiovascular events in type 2 diabetes with atherosclerotic cardiovascular disease, chronic kidney disease, or both.

Does not show: an injectable-product result. Oral and injectable are different objects.

Off-label discussion

PMID 37385278 — OASIS 1

Tested: once-daily oral semaglutide versus placebo for weight in adults with overweight or obesity.

Does not show: the labeled injectable obesity product, or a labeled oral obesity tablet. Different product.

PMID 40169145 — STRIDE

Tested: injectable semaglutide versus placebo for walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes.

Does not show: a labeled PAD-walking use. There is not a US label for that claim.

PMID 40544432 — REDEFINE 2 (CagriSema)

Tested: cagrilintide plus semaglutide versus comparators in adults with overweight or obesity and type 2 diabetes.

Does not show: semaglutide monotherapy. This is an unapproved combination.

What is not established

A paper on one labeled pair is not a protocol for another use, another product, or a non-trial preparation. Oral high-dose obesity product, PAD walking, and CagriSema are not labeled claims on this page. Compounded, research-use, or analog products were not the trial objects.

Selected sources

33567185 35015037 38330988 37952131 27633186 40305708 40162642 37385278 40169145 40544432

What people discuss

Reported experiences

Blood sugar, appetite, weight, cardiovascular risk

Reported topics are not established benefits.
Watch for

Risks and unknowns

Gastrointestinal effects, dehydration, gallbladder and pancreatic concerns, product errors

Context matters. Approval of one medicine, formulation, or use does not establish approval of products sold online or other uses. This page is educational and does not provide dosing or treatment advice.
Member discussion

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