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Completed

NCT Number: NCT06445075

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ProSciento CRU, Chula Vista, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • ≥30.0 kg/m2 to ≤45.0 kg/m2 or
  • ≥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

Treatment and study plan

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.

Other names: SRK-015

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.

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.

Other names: ZEPBOUND

Primary outcomes

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

    Time frame: Baseline and 24 weeks

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

Secondary outcomes

  1. Change from Baseline in body weight

    Time frame: Baseline and 24 weeks

    Total body weight was assessed via a calibrated scale

  2. Change from Baseline in percent lean body mass (%)

    Time frame: Baseline and 24 weeks

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

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

    Time frame: Baseline and 24 weeks

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

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

    Time frame: Baseline and 24 weeks

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

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

    Time frame: Baseline and 24 weeks

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

  6. Percent (%) of weight loss from baseline due to lean body mass loss

    Time frame: Baseline and 24 weeks

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

  7. Concentration of apitegromab in circulation over time

    Time frame: Baseline up to 40 weeks

    Blood samples were assessed for circulating concentration of apitegromab

  8. Concentration of latent myostatin in circulation over time

    Time frame: Baseline up to 24 weeks

    Blood samples were assessed for circulating concentration of latent myostatin

  9. Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Baseline up to 40 weeks

    Incidence and severity of TEAEs and SAEs

  10. Presence of anti-drug antibodies (ADA) against apitegromab over time

    Time frame: Baseline up to 40 weeks

    Measured in serum blood samples

Other outcomes

  1. Change from Baseline in HbA1c

    Time frame: Baseline up to 32 weeks

    Blood samples were assessed for HbA1c (glycated hemoglobin)

  2. Change from baseline in fasting serum triglycerides

    Time frame: Baseline up to 32 weeks

    Blood samples were assessed for fasting serum triglycerides

  3. Change from baseline in total cholesterol

    Time frame: Baseline up to 32 weeks

    Blood samples were assessed for total cholesterol

  4. Change from baseline in low-density lipoprotein cholesterol (LDL-C)

    Time frame: Baseline up to 32 weeks

    Blood samples were assessed for low-density lipoprotein cholesterol (LDL-C)

Sponsors and collaborators

Lead sponsor

Scholar Rock, Inc.

Industry

Registry information

Official study 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

Acronym: EMBRAZE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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