NCT06445075

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

A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apitegromab in Overweight and Obese Adult Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Scholar Rock, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This phase 2 randomized, double-blind, placebo-controlled, multicenter study assessed the safety, efficacy, and pharmacokinetics (PK) of apitegromab when used as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight and obesity and without diabetes. Each subject received tirzepatide throughout the treatment period. In addition, all subjects were randomized 1:1 to receive either apitegromab or placebo during the treatment period.

Conditions

• Overweight and Obesity

Interventions

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

Timeline

• Start date: 2024-05-21
• Primary completion: 2025-03-04
• Completion: 2025-06-17
• First posted: 2024-06-06
• Last updated: 2026-01-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study