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Metabolic & endocrine

Apitegromab

An investigational antibody that inhibits myostatin activation, with a peer-reviewed Phase 2 trial showing less DXA-measured lean-mass loss during tirzepatide treatment, but no proven functional outcome in obesity.

L4Good human trialsIn clinical trialsIn clinical developmentBiologic / other
How settled this rating is:
moderate confidence in the current evidence rating
Routes studied:
Intravenous
Also known as:
SRK-015
Last reviewed:
2026-10-03
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Evidence passport

Apitegromab

A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.

Reviewed 2026-10-03
Evidence level
L4Good human trials
Confidence
Moderate confidence in rating
Regulatory status
In clinical trials
Development status
In clinical development

Evidence strength

Human efficacy evidence62 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Human safety evidence40 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.

Evidence base
Includes human studies
Furthest established stage
Phase II
Human research maturity
Completed randomized, double-blind, placebo-controlled Phase 2 (EMBRAZE) in obesity; peer reviewed in Nature Medicine, 8 June 2026
Source curation
Sources fully curated

Routes recorded

IV

Overview

Human efficacy evidence strength62 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Preclinical (animal / lab) evidence strength65 of 100 evidence strength

Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.

Human safety evidence strength40 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

Evidence for the assessed benefit

L4Good human trialsModerate confidence in rating

Controlled Phase 2 evidence supports less DXA-measured lean-mass loss during tirzepatide-associated weight loss over 24 weeks. DXA lean mass is not synonymous with skeletal muscle, and the trial does not establish better strength, mobility, frailty or long-term outcomes.

Human research context: 102 adults with overweight or obesity receiving tirzepatide in EMBRAZE.

Research maturity, benefit evidence, safety and approval are different questions.

How to read these scores

Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.

  • Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
  • Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
  • Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
  • Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
  • Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.

None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.

How far human research has progressed: Completed randomized, double-blind, placebo-controlled Phase 2 (EMBRAZE) in obesity; peer reviewed in Nature Medicine, 8 June 2026

Routes & formulations

Studied / approved routes

IV

Studied as an intravenous infusion in clinical trials. This describes the trial route only, not advice for use.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

    Furthest established stage

  5. Phase III

  6. Approved

In clinical development

Proof-of-concept Phase 2 completed in obesity.

Last documented development: 8 June 2026 — EMBRAZE Phase 2 published in Nature Medicine

What it is

A fully human monoclonal antibody that selectively binds the precursor forms of myostatin and inhibits their activation, without reported activity toward other TGFβ-family members.

What people claim

  • Reduces lean-mass loss during GLP-1-based weight loss
  • Improves strength or prevents frailty in obesity

What the evidence actually says

In EMBRAZE (randomized, double-blind, placebo-controlled; 102 adults on tirzepatide), apitegromab resulted in a least-squares mean of 1.9 kg (80% CI 1.2–2.7) less DXA-measured lean-mass loss than placebo at week 24 (P = 0.001), with similar total weight loss; lean-mass loss was 1.6 kg versus 3.5 kg, reported as 54.9% relative retention. This is a body-composition endpoint, not proof of better physical function in obesity.

Useful next reads based on this compound — not recommendations.

Human evidence

  • EMBRAZE: week-24 lean-mass loss 1.6 kg with apitegromab versus 3.5 kg with placebo, both alongside tirzepatide; difference 1.9 kg (80% CI 1.2–2.7), reported as 54.9% relative retention.
  • Total body-weight loss was similar between groups.
  • No functional, falls, frailty or long-term clinical outcome is established by this trial.

Preclinical evidence

  • In mouse models of muscle atrophy, apitegromab increased lean mass, muscle size and force; animal findings do not establish human functional benefit.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Blocks activation of myostatin, a signal that limits skeletal-muscle growth.
  • Intended to change the composition of weight lost, not to cause weight loss itself.

Safety and unknowns

  • The paper describes the drug as well tolerated in this 24-week proof-of-concept study; it is too small and short to establish long-term or uncommon risks.

Cancer relevance

This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.

Monitored in trials; not demonstrated in humans

No human cancer effect is established in our record.

Regulatory status

Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.

Check the regulatory note and linked primary sources for jurisdiction-specific details.

Not approved for any indication in our record. Obesity/body-composition use is investigational.

Evidence grade

L4Good human trialsModerate confidence in rating

Completed, adequately informative controlled human trials supporting a specified outcome; replication and longer-term safety may remain uncertain.

What would change our rating?

  • Larger, longer trials with strength, mobility or other patient-important outcomes.
  • Replication in older adults or people with low muscle mass.

References and sources

Source transparency

A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.

Sources fully curated
Last editorial review
2026-10-03
Recently reviewed · 13 days ago
Linked curated sources
1
Sources still pending
0
External specialist reviews
0
None recorded for this profile
Peer-reviewed: 1

Review provenance

Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.

Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

These entries record changes to our assessment of the published evidence — not changes to the compound itself.

  1. Added apitegromab with the Nature Medicine EMBRAZE Phase 2 trial: 1.9 kg less DXA-measured lean-mass loss than placebo at week 24 in 102 adults on tirzepatide (reported 54.9% relative retention).

    Change 1 of 1
    L4Good human trials
    Added at L4 for the specified lean-mass endpoint. DXA lean mass is not a functional outcome; strength, mobility and frailty benefits are not established. Reviewed 3 October 2026.