Overweight and Obesity
Conditions
Keywords
Overweight, Obesity
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.
Interventions
DRUGApitegromab
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.
DRUGPlacebo
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.
DRUGTirzepatide
Glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Tirzepatide was administered every week by subcutaneous injection.
Sponsors
Scholar Rock, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Active treatment, randomized, double-blind, placebo-controlled
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed