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

Launched by SCHOLAR ROCK, INC. · May 30, 2024

Keywords

ClinConnect Summary

This phase 2 randomized, double-blind, placebo-controlled, multicenter study will assess the safety, efficacy, and pharmacokinetics (PK) of apitegromab when used as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight and obesity and without diabetes. Each subject will receive either semaglutide or tirzepatide, depending upon availability, and will maintain that course throughout the treatment period. In addition, all subjects will be randomized 1:1 to receive either apitegromab or placebo during the treatment period.

Gender

ALL

Eligibility criteria

• • 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