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

Part of paid clinical trials in Chula Vista, California.

Sponsor
Scholar Rock, Inc.
Study ID
NCT06445075
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
May 21, 2024
Status verified
Jan 2026
Primary completion
Mar 4, 2025
Completion
Jun 17, 2025

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Apitegromab + incretin mimetic
  • Placebo Comparator: Cohort 2
    Placebo + incretin mimetic

Primary Outcome Measure

Change from Baseline in total Lean Body Mass (kg) at 24 weeks [ Time Frame: Baseline and 24 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
ProSciento CRUChula VistaCalifornia91911-
AdventHealth Translational Research InstituteOrlandoFlorida32804-
Great Lakes Clinical Trials, LLC d/b/a Flourish ResearchChicagoIllinois60640-
Tandem Clinical Research GI, LLCMarreroLouisiana70072-
Alliance for Multispecialty Research, LLCNormanOklahoma73069-
Apex Mobile Clinical ResearchBellaireTexas77401-
Clinical Trials of Texas, LLC dba Flourish ResearchSan AntonioTexas78229-

Find similar trials in Chula Vista, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
ProSciento CRU· Chula Vista, CAAdventHealth Translational Research Institute· Orlando, FLGreat Lakes Clinical Trials, LLC d/b/a Flourish Research· Chicago, ILTandem Clinical Research GI, LLC· Marrero, LAAlliance for Multispecialty Research, LLC· Norman, OKApex Mobile Clinical Research· Bellaire, TX

Related Studies