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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
NCT06445075 on ClinicalTrials.gov

Status: CompletedResults none
Who it enrolls: age 18 Years to 65 Years; healthy volunteers accepted; excludes diabetes; no BMI minimum stated; conditions: Overweight and Obesity
Interventions: Apitegromab; Placebo; Tirzepatide
Conditions: Overweight and Obesity
Phase and size: Phase 2 · 102 participants
Dates: Start 2024-05-21
Primary completion 2025-03-04
Sponsor: Scholar Rock, Inc. (Industry)
Last checked: Sep 13, 2026

01Endpoints

What the trial will measure

Change from Baseline in total Lean Body Mass (kg) at 24 weeksBaseline and 24 weeks

Published results in the collection

Apitegromab for lean mass preservation during tirzepatide-induced weight loss: a randomized, double-blind, placebo-controlled phase 2 trialRandomized trial · 2026 · Study tier 3 · Different population · Mixed · Industry funded

02Eligibility

Who can take part

Inclusion Criteria * Able to comprehend the informed consent process and provide written informed consent prior to study enrollment and the conduct of any study-related assessments to study enrollment and the conduct of any study-related assessments * Male or female, age ≥ 18 and ≤ 65 years at the time of informed consent * Stable body weight (±5 kg) within 90 days of Screening * At Screening, a BMI of: 1. ≥30.0 kg/m2 to ≤45.0 kg/m2 or 2. ≥27.0 kg/m2 to \<30.0 kg/m2 with the presence of 1 or more weight-related comorbid condition(s). Note: See exclusion criteria for specific organ class disease parameters Exclusion Criteria: * History of or active cardiovascular, neurovascular, peripheral vascular, pulmonary, hepatic, pancreatic, neuromuscular, and/or psychiatric disease * Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas * History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to Screening * History of Type 1 diabetes or active Type 2 diabetes (T2D). If there was a history of T2D and it resolved, then the resolution must have occurred \>12 months prior to Screening. Prediabetes managed with nonpharmacologic approaches (exercise and diet) is not an exclusion

03Change log

Registry changes

No changes recorded since the trial was added.