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

Overweight and Obesity Clinical Trial

— EMBRAZE  

Official title:

A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apitegromab in Overweight and Obese Adult Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06445075
• Other study ID #: SRK-015-006
• Status: Recruiting
• Phase: Phase 2
• Start date: May 21, 2024
• Est. completion date: October 20, 2025

Study information

• Verified date: May 2024
• Source: Scholar Rock, Inc.
• Contact: Scholar Rock, Inc. Clinical Trials Administration
• Phone: 857-259-3860
• Email: clinicaltrials[@]scholarrock.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight or obesity

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 20, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Drug:
• Apitegromab
Apitegromab (SRK-015) is a fully human anti-proMyostatin monoclonal antibody (mAb) that specifically binds to human pro/latent myostatin, inhibiting myostatin activation. Apitegromab will be administered every 4 weeks by intravenous (IV) infusion.
• Placebo
Same appearance and composition as apitegromab drug product but does not contain the active ingredient. Placebo will be administered every 4 weeks by intravenous (IV) infusion.
• Semaglutide
Glucagon-like peptide-1 (GLP-1) receptor agonist. Semaglutide will be administered every week by subcutaneous injection.
• Tirzepatide
Glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Tirzepatide will be administered every week by subcutaneous injection.

Locations

Country	Name	City	State
United States	Apex Mobile Clinical Research	Bellaire	Texas
United States	ProSciento CRU	Chula Vista	California
United States	Clinical Trials of Texas, LLC dba Flourish Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Scholar Rock, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline in HbA1c	Blood samples will be assessed for HbA1c (glycated hemoglobin)	Baseline up to 32 weeks
Other	Change from baseline in fasting serum triglycerides	Blood samples will be assessed for fasting serum triglycerides	Baseline up to 32 weeks
Other	Change from baseline in total cholesterol	Blood samples will be assessed for total cholesterol	Baseline up to 32 weeks
Other	Change from baseline in low-density lipoprotein cholesterol (LDL-C)	Blood samples will be assessed low-density lipoprotein cholesterol (LDL-C)	Baseline up to 32 weeks
Primary	Change from Baseline in total Lean Body Mass (kg) at 24 weeks	Dual-energy X-ray absorptiometry will be used to evaluate body composition	Baseline and 24 weeks
Secondary	Change from Baseline in body weight	Total body weight will be assessed via a calibrated scale	Baseline and 24 weeks
Secondary	Change from Baseline in percent lean body mass (%)	Dual-energy X-ray absorptiometry will be used to evaluate body composition	Baseline and 24 weeks
Secondary	Change from Baseline in fat body mass (kg and %)	Dual-energy X-ray absorptiometry will be used to evaluate body composition	Baseline and 24 weeks
Secondary	Change from Baseline in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and trunk fat body mass (kg and %)	Dual-energy X-ray absorptiometry will be used to evaluate body composition	Baseline and 24 weeks
Secondary	Percent (%) of weight loss from baseline due to fat body mass loss	Dual-energy X-ray absorptiometry will be used to evaluate body composition	Baseline and 24 weeks
Secondary	Percent (%) of weight loss from baseline due to lean body mass loss	Dual-energy X-ray absorptiometry will be used to evaluate body composition	Baseline and 24 weeks
Secondary	Concentration of apitegromab in circulation over time	Blood samples will be assessed for circulating concentration of apitegromab	Baseline up to 40 weeks
Secondary	Concentration of latent myostatin in circulation over time	Blood samples will be assessed for circulating concentration of latent myostatin	Baseline up to 24 weeks
Secondary	Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)	Incidence and severity of TEAEs and SAEs	Baseline up to 40 weeks
Secondary	Presence of anti-drug antibodies (ADA) against apitegromab over time	Measured in serum blood samples	Baseline up to 40 weeks