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

Completed · Phase 2 · Has a placebo group

Conditions studied: Overweight and Obesity

In brief

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 facts

Study ID

NCT06445075

Run by

Scholar Rock, Inc.

People needed

102

Starts

2024-05-21

Expected to finish

2025-06-17

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• ≥30.0 kg/m2 to ≤45.0 kg/m2 or
• ≥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

You may not qualify if…

• 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

Where it is running

• ProSciento CRU — Chula Vista, California, United States
• AdventHealth Translational Research Institute — Orlando, Florida, United States
• Great Lakes Clinical Trials, LLC d/b/a Flourish Research — Chicago, Illinois, United States
• Tandem Clinical Research GI, LLC — Marrero, Louisiana, United States
• Alliance for Multispecialty Research, LLC — Norman, Oklahoma, United States
• Apex Mobile Clinical Research — Bellaire, Texas, United States
• Clinical Trials of Texas, LLC dba Flourish Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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