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Trial · Interventional

CompletedPhase 2Registry data

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

Short name EMBRAZE

NCTNCT06445075 (opens ClinicalTrials.gov in a new tab)Other idSRK-015-006
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
102 participants (actual)
Sponsor
Scholar Rock, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
21 May 2024
Primary completion
4 Mar 2025
Completion
17 Jun 2025
First posted
6 Jun 2024
Last update posted
23 Jan 2026
Conditions
Overweight and Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 2

    EMBRAZE

    NCT06445075

    21 May 2024 to 17 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • ApitegromabDrug
  • PlaceboDrug
  • TirzepatideDrug

Arms2

  • Experimental

    Cohort 1

    Apitegromab + incretin mimetic

  • Placebo comparator

    Cohort 2

    Placebo + incretin mimetic

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline and 24 weeks

    Registry description

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

Secondary outcomes(10)

  1. Change from Baseline in body weight

    Time frame · Baseline and 24 weeks

    Registry description

    Total body weight was assessed via a calibrated scale

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

    Time frame · Baseline and 24 weeks

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Measured in serum blood samples

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

5 results

Apitegromab for lean mass preservation during tirzepatide-induced weight loss: a randomized, double-blind, placebo-controlled phase 2 trial.

Pratley et al. 2026Nature medicinecited by 9

PMID 42260100PMC13375528DOI 10.1038/s41591-026-04440-4PUB-42260100

CC BY5 results
Download PDFSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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