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

NCT06445075 | Completed Phase 2 FDA Drug

• 1 other identifier: SRK-015-006
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 7

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

Conditions

Overweight and Obesity

Keywords

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in total Lean Body Mass (kg) at 24 weeks

  Dual-energy X-ray absorptiometry was used to evaluate body composition

  Baseline and 24 weeks

Secondary Outcomes (10)

• Change from Baseline in body weight

  Baseline and 24 weeks

• Change from Baseline in percent lean body mass (%)

  Baseline and 24 weeks

• Change from Baseline in fat body mass (kg and %)

  Baseline and 24 weeks

• Change from Baseline in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and trunk fat body mass (kg and %)

  Baseline and 24 weeks

• Percent (%) of weight loss from baseline due to fat body mass loss

  Baseline and 24 weeks

Other Outcomes (4)

• Change from Baseline in HbA1c

  Baseline up to 32 weeks

• Change from baseline in fasting serum triglycerides

  Baseline up to 32 weeks

• Change from baseline in total cholesterol

  Baseline up to 32 weeks

Study Arms (2)

Cohort 1

EXPERIMENTAL

Apitegromab + incretin mimetic

Drug: Apitegromab; Drug: Tirzepatide

Cohort 2

PLACEBO COMPARATOR

Placebo + incretin mimetic

Drug: Placebo; Drug: Tirzepatide

Interventions

Apitegromab DRUG

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.

Also known as: SRK-015

Cohort 1

Tirzepatide DRUG

Glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Tirzepatide was administered every week by subcutaneous injection.

Also known as: ZEPBOUND

Cohort 1; Cohort 2

Placebo DRUG

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.

Cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Scholar Rock, Inc.: lead

Study Sites (7)

ProSciento CRU

Chula Vista, California, 91911, United States

Location

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

Great Lakes Clinical Trials, LLC d/b/a Flourish Research

Chicago, Illinois, 60640, United States

Location

Tandem Clinical Research GI, LLC

Marrero, Louisiana, 70072, United States

Location

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, 73069, United States

Location

Apex Mobile Clinical Research

Bellaire, Texas, 77401, United States

Location

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

apitegromab; Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active treatment, randomized, double-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 6, 2024
• Study Start: May 21, 2024
• Primary Completion: March 4, 2025
• Study Completion: June 17, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (7)