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

January 20, 2026 updated by: Scholar Rock, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • ProSciento CRU
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Translational Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials, LLC d/b/a Flourish Research
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research GI, LLC
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Bellaire, Texas, United States, 77401
        • Apex Mobile Clinical Research
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, LLC dba Flourish Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
Apitegromab + incretin mimetic
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 was administered every 4 weeks by intravenous (IV) infusion.
Other Names:
  • SRK-015
Drug: Tirzepatide
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
Placebo Comparator: Cohort 2
Placebo + incretin mimetic
Drug: Tirzepatide
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
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame: Baseline up to 40 weeks
Incidence and severity of TEAEs and SAEs
Baseline up to 40 weeks
Presence of anti-drug antibodies (ADA) against apitegromab over time
Time Frame: Baseline up to 40 weeks
Measured in serum blood samples
Baseline up to 40 weeks
Change from Baseline in body weight
Time Frame: Baseline and 24 weeks
Total body weight was assessed via a calibrated scale
Baseline and 24 weeks
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
Baseline and 24 weeks
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
Baseline and 24 weeks
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
Baseline and 24 weeks
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
Baseline and 24 weeks
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
Baseline and 24 weeks
Concentration of apitegromab in circulation over time
Time Frame: Baseline up to 40 weeks
Blood samples were assessed for circulating concentration of apitegromab
Baseline up to 40 weeks
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
Baseline up to 24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in HbA1c
Time Frame: Baseline up to 32 weeks
Blood samples were assessed for HbA1c (glycated hemoglobin)
Baseline up to 32 weeks
Change from baseline in fasting serum triglycerides
Time Frame: Baseline up to 32 weeks
Blood samples were assessed for fasting serum triglycerides
Baseline up to 32 weeks
Change from baseline in total cholesterol
Time Frame: Baseline up to 32 weeks
Blood samples were assessed for total cholesterol
Baseline up to 32 weeks
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)
Baseline up to 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Scholar Rock, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SRK-015-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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