Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese
- Conditions
- Overweight and Obesity
- Interventions
- Registration Number
- NCT06445075
- Lead Sponsor
- Scholar Rock, Inc.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Apitegromab Apitegromab + incretin mimetic Cohort 1 Tirzepatide Apitegromab + incretin mimetic Cohort 2 Placebo Placebo + incretin mimetic Cohort 2 Tirzepatide Placebo + incretin mimetic
- Primary Outcome Measures
Name Time Method Change from Baseline in total Lean Body Mass (kg) at 24 weeks Baseline and 24 weeks Dual-energy X-ray absorptiometry was used to evaluate body composition
- Secondary Outcome Measures
Name Time Method Change from Baseline in body weight Baseline and 24 weeks Total body weight was assessed via a calibrated scale
Change from Baseline in percent lean body mass (%) Baseline and 24 weeks Dual-energy X-ray absorptiometry was used to evaluate body composition
Change from Baseline in fat body mass (kg and %) Baseline and 24 weeks Dual-energy X-ray absorptiometry was used to evaluate body composition
Change from Baseline in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and trunk fat body mass (kg and %) Baseline and 24 weeks Dual-energy X-ray absorptiometry was used to evaluate body composition
Percent (%) of weight loss from baseline due to fat body mass loss Baseline and 24 weeks Dual-energy X-ray absorptiometry was used to evaluate body composition
Percent (%) of weight loss from baseline due to lean body mass loss Baseline and 24 weeks Dual-energy X-ray absorptiometry was used to evaluate body composition
Concentration of apitegromab in circulation over time Baseline up to 40 weeks Blood samples were assessed for circulating concentration of apitegromab
Concentration of latent myostatin in circulation over time Baseline up to 24 weeks Blood samples were assessed for circulating concentration of latent myostatin
Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) Baseline up to 40 weeks Incidence and severity of TEAEs and SAEs
Presence of anti-drug antibodies (ADA) against apitegromab over time Baseline up to 40 weeks Measured in serum blood samples
Trial Locations
- Locations (7)
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
ProSciento CRU🇺🇸Chula Vista, California, United States