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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
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.
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.
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
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
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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
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