Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese

NCT06445075 · Completed

Last updated 2026-05-28

This clinical trial tests whether apitegromab can safely increase muscle mass in adults who are overweight or obese over a 24-week period.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 102 people

Who can join Ages 18–65 · all sexes Healthy volunteers accepted.

Timeline Started 2024-05 · est. completion 2025-06

Where 7 sites · United States

What this study is testing ClinicalTrials.gov NCT06445075 ↗

Description as written by the study sponsor.

A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight or obesity

Treatments tested

Apitegromab also known as SRK-015 Drug

Apitegromab (SRK-015) is a fully human anti-proMyostatin monoclonal antibody (mAb) that specifically binds to human pro/latent myostatin, inhibiting myostatin activation. Apitegromab was administered every 4 weeks by intravenous (IV) infusion.
Placebo Drug

Same appearance and composition as apitegromab drug product but does not contain the active ingredient. Placebo was administered every 4 weeks by intravenous (IV) infusion.
Tirzepatide also known as ZEPBOUND Drug

Glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Tirzepatide was administered every week by subcutaneous injection.

Main thing measured	Change from Baseline in total Lean Body Mass (kg) at 24 weeks
Sponsor	Scholar Rock, Inc.
Conditions studied	Overweight and Obesity
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06445075 ↗