Has PLATEAU finished enrolling?

The registry lists it as recruiting with 200 as an estimated enrolment. Company announcements about enrolment milestones routinely precede the registry record being updated, so the two can disagree for a period; the registry is the record that can be checked.

What did QUALITY find?

Its registered primary endpoint was percentage change in total lean body mass at 112 days and it completed in April 2025. Any figure quoted for it should be traced to a published report or a company release rather than inferred from the trial's existence.

Is a SARM the same kind of thing as a GLP-1 drug?

No. Enobosarm acts at the androgen receptor; incretin agents act at gut hormone receptors. They are combined here because they address different components of the same outcome, not because they share a mechanism.

Why does the age threshold matter?

Because lean mass loss during weight reduction is a larger concern in older adults, who have less reserve. It also limits what the trials can support: neither enrolled younger participants, so neither speaks to them.

Research & Regulatory News

A Muscle Trial That Changed Its Primary Endpoint

JMWritten & reviewed by Jack Muncaster · Founder, UK PeptidesLast reviewed 2026-08-242 cited sources

PLATEAU (NCT07446998) is a Phase 2b trial of enobosarm added to semaglutide in 200 adults aged 65 and over. Its predecessor QUALITY had total lean body mass as its primary endpoint; PLATEAU's registered primary endpoint is instead total body weight, measured at day 476.

Key facts

PLATEAU registration: NCT07446998
Registered acronym: PLATEAU
Design: Phase 2b, randomised, triple-masked, placebo-controlled
Enrolment: 200 (estimated)
Population: Aged 65 and over
Primary endpoint: Total body weight versus semaglutide alone, at day 476
Predecessor: QUALITY (NCT06282458), 168 actual, completed 11 April 2025
QUALITY primary endpoint: Percentage change in total lean body mass at 112 days

What is being tested

Enobosarm is a selective androgen receptor modulator, given orally. The rationale for combining it with a GLP-1 receptor agonist is the lean-mass question: substantial weight loss on incretin therapy includes a proportion of fat-free mass, and an agent that preserves muscle during that loss would change the composition of what is lost. Veru's programme has run two trials on this combination. QUALITY (NCT06282458) was a Phase 2 dose-finding study of 168 participants aged 60 and over, comparing semaglutide plus enobosarm 3 mg or 6 mg daily against a GLP-1 receptor agonist plus placebo, and it completed on 11 April 2025. PLATEAU (NCT07446998) is the Phase 2b successor: 200 participants aged 65 and over, semaglutide plus enobosarm 3 mg against semaglutide plus placebo, started 26 March 2026 with primary completion in October 2027.

The endpoint changed, and that is the story

QUALITY's primary endpoint, as registered, was the percentage change from baseline in total lean body mass at 112 days. That is the mechanistic endpoint - it measures the thing the drug is supposed to do. PLATEAU's registered primary endpoint is to determine the effect of enobosarm in combination with semaglutide on total body weight compared with semaglutide alone, at day 476. Total fat mass appears as a secondary endpoint. That is a different question about the same combination, over four times the duration.

Why the direction of that endpoint is not obvious

For an agent whose purpose is preserving lean mass, an effect on total body weight is ambiguous. Muscle is denser than fat and contributes mass; successfully preserving lean tissue while fat is lost could leave total weight loss unchanged or smaller than semaglutide alone produces. A trial whose primary endpoint is total body weight is therefore not straightforwardly testing the mechanistic hypothesis, and the endpoint that would test it most directly - fat mass, or the ratio of fat to lean loss - sits in the secondary position. This is not a criticism of the design, which may reflect what a regulator has indicated it wants to see; it is a reason to read the eventual result carefully rather than as a simple test of muscle preservation.

The populations are narrow, and deliberately so

QUALITY enrolled adults aged 60 and over; PLATEAU raises that to 65 and over. Older adults lose proportionally more lean mass during weight reduction and have less to spare, so the concern the drug addresses is concentrated in that group. It also means neither trial says anything about younger populations, and results from either should not be generalised beyond the age range enrolled. Both trials are triple-masked, which is a stronger masking specification than the double-blind description usually reported.

Where this sits among muscle-preservation programmes

Several approaches are being tried against the same problem by different mechanisms: activin receptor pathway blockade, myostatin-directed agents, and selective androgen receptor modulation as here. None has produced a licensed agent for this purpose, and the field has already produced one instructive failure in bimagrumab's withdrawn trial. The common difficulty is that preserving lean mass is easy to demonstrate on a scan and hard to connect to an outcome anyone can feel, which is why physical function measures appear in these designs alongside body composition.

What this does not mean

Enobosarm is investigational and is not licensed anywhere for weight management or muscle preservation. Selective androgen receptor modulators are not supplied on this site and nothing here is a version of one. Semaglutide is a licensed prescription medicine; research material is not an alternative to it, and the dose arms described here are facts about registered trials conducted under clinical supervision, not guidance of any kind.

Quick reference

	QUALITY	PLATEAU
Registration	NCT06282458	NCT07446998
Phase	2	2b
Enrolment	168 (actual)	200 (estimated)
Age	60 and over	65 and over
Primary endpoint	Total lean body mass	Total body weight
Timepoint	112 days	Day 476
Status	Completed 11 April 2025	Recruiting

Extended research context

The Research & Regulatory News deep dive

Deep dive: why 2026 was the year the incretin field split in two

For a decade every meaningful GLP-1 medicine was a peptide, and every one of them was injected. 2026 broke that pattern in both directions at once. In August the MHRA authorised orforglipron, a small molecule with no peptide bonds that works as an ordinary daily tablet. Three months earlier, retatrutide's TRIUMPH-1 reported a 28.3% mean weight reduction — the largest figure yet from a single molecule, and achievable only with a peptide capable of engaging three receptors at once. The field is not converging on one answer; it is separating into a convenience track and a magnitude track, and those tracks have different chemistry.

Deep dive: what a marketing authorisation actually means

An authorisation is granted to a specific product, in a specific formulation, for a specific indication, by a specific regulator. It is not a statement about a compound class and it does not transfer. Orforglipron being licensed in the UK tells you nothing about the legal or regulatory status of any other incretin, and nothing at all about compounds that remain investigational. Authorisation is also separate from funding: a licensed medicine is not automatically available on the NHS, which requires a further NICE appraisal.

Deep dive: reading trial results without being misled

Headline percentages are the least transferable part of a trial. A figure is only meaningful alongside its population, its duration, its comparator and its dropout rate. TRIUMPH-1's 28.3% came from an 80-week study in a relatively uncomplicated obesity population; TRIUMPH-3's 22.6% came from adults with severe obesity and established cardiovascular disease, and the gap between those two numbers is mostly population, not potency. Discontinuation rates deserve the same attention as efficacy: 11.3% of the TRIUMPH-1 12 mg arm stopped due to adverse events against 4.9% on placebo, and that figure is routinely dropped from summaries.

Research applications

▸Tracking regulatory status of investigational incretin compounds
▸Understanding the difference between authorisation, NICE appraisal and NHS availability
▸Comparing peptide and non-peptide receptor agonist pharmacology
▸Interpreting Phase 3 topline releases before peer-reviewed publication
▸Verifying trial identity against ClinicalTrials.gov registrations

Handling checklist

✓Check the compound named in a trial registration matches the compound being discussed
✓Confirm the NCT identifier resolves to the acronym being cited
✓Read topline press releases as preliminary until peer-reviewed publication
✓Separate the trial population from the headline percentage before comparing studies
✓Treat authorisation in one jurisdiction as saying nothing about status in another

Common research-handling mistakes

Learnt from thousands of researcher orders across our UK labs.

✗ Treating a positive Phase 3 as approval

Fix: Filing begins a review that commonly takes a year or more and can end in a request for more data.

✗ Comparing weight-reduction percentages across different trials

Fix: Population, duration and comparator differ; the numbers are not interchangeable.

✗ Assuming one incretin's approval legitimises another compound

Fix: Authorisations are product-specific and do not transfer between compounds.

✗ Citing a TRIUMPH number without checking the NCT identifier

Fix: Verify against ClinicalTrials.gov — the numbering has been widely misreported.

✗ Reading research material as an alternative to a licensed medicine

Fix: Research material is supplied for laboratory use only and is not a substitute for anything prescribed.

Continue researching

Peer-reviewed guides, comparators and matched reference materials.

Frequently asked questions

Has PLATEAU finished enrolling?: The registry lists it as recruiting with 200 as an estimated enrolment. Company announcements about enrolment milestones routinely precede the registry record being updated, so the two can disagree for a period; the registry is the record that can be checked.
What did QUALITY find?: Its registered primary endpoint was percentage change in total lean body mass at 112 days and it completed in April 2025. Any figure quoted for it should be traced to a published report or a company release rather than inferred from the trial's existence.
Is a SARM the same kind of thing as a GLP-1 drug?: No. Enobosarm acts at the androgen receptor; incretin agents act at gut hormone receptors. They are combined here because they address different components of the same outcome, not because they share a mechanism.
Why does the age threshold matter?: Because lean mass loss during weight reduction is a larger concern in older adults, who have less reserve. It also limits what the trials can support: neither enrolled younger participants, so neither speaks to them.

Primary sources & clinical trials

Peer-reviewed research and registered trials from PubMed, ClinicalTrials.gov, PubChem, FDA and NIH. All links open in a new tab and point to the primary source, so every claim can be verified at origin.

Written and reviewed by

Jack Muncaster · Founder, UK Peptides

Jack founded UK Peptides in Manchester after repeatedly receiving research compounds with missing or recycled paperwork. He is responsible for supplier selection, batch release decisions and the content published in this research library. Every article here is sourced to primary literature and every product page to a signed third-party certificate.

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