A Phase 2 interventional study of Apitegromab and Placebo in Overweight and Obesity, sponsored by Scholar Rock, Inc.. Completed at 7 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Scholar Rock, Inc. · Phase 2, Interventional, and Treatment
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
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.
At Screening, a BMI of:
Exclusion Criteria:
Apitegromab + incretin mimetic
Drug: Apitegromab · Drug: Tirzepatide
Placebo + incretin mimetic
Drug: Placebo · Drug: Tirzepatide
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.
Also known as: SRK-015
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.
Glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Tirzepatide was administered every week by subcutaneous injection.
Also known as: ZEPBOUND
Change from Baseline in total Lean Body Mass (kg) at 24 weeks
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Change from Baseline in body weight
Total body weight was assessed via a calibrated scale
Time frame: Baseline and 24 weeks
Change from Baseline in percent lean body mass (%)
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Change from Baseline in fat body mass (kg and %)
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Change from Baseline in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and trunk fat body mass (kg and %)
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Percent (%) of weight loss from baseline due to fat body mass loss
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Percent (%) of weight loss from baseline due to lean body mass loss
Dual-energy X-ray absorptiometry was used to evaluate body composition
Time frame: Baseline and 24 weeks
Concentration of apitegromab in circulation over time
Blood samples were assessed for circulating concentration of apitegromab
Time frame: Baseline up to 40 weeks
Concentration of latent myostatin in circulation over time
Blood samples were assessed for circulating concentration of latent myostatin
Time frame: Baseline up to 24 weeks
Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Incidence and severity of TEAEs and SAEs
Time frame: Baseline up to 40 weeks
Presence of anti-drug antibodies (ADA) against apitegromab over time
Measured in serum blood samples
Time frame: Baseline up to 40 weeks
Change from Baseline in HbA1c
Blood samples were assessed for HbA1c (glycated hemoglobin)
Time frame: Baseline up to 32 weeks
Change from baseline in fasting serum triglycerides
Blood samples were assessed for fasting serum triglycerides
Time frame: Baseline up to 32 weeks
Change from baseline in total cholesterol
Blood samples were assessed for total cholesterol
Time frame: Baseline up to 32 weeks
Change from baseline in low-density lipoprotein cholesterol (LDL-C)
Blood samples were assessed for low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline up to 32 weeks
Plan to share: Yes
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Scholar Rock, Inc.