EMBRAZE

CompletedPhase 2

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

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

Lead sponsor

Scholar Rock, Inc.

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

102

actual

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Lean mass

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06445075

Org study IDSRK-015-006

Timeline

Milestones

Study start2024-05-21actual

Study first posted2024-06-06actual

Primary completion2025-03-04actual

Study completion2025-06-17actual

Last update posted2026-01-23actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

Other (unclassified)

Weight & body composition

7 endpoints

Primary/protocol endpoint

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

Time frame:Baseline and 24 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in body weight

Time frame:Baseline and 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in percent lean body mass (%)

Time frame:Baseline and 24 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and 24 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and 24 weeks

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and 24 weeks

Lean mass

percent change from baseline, improvement

Glycemic / diabetes

1 endpoint

Other/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline up to 32 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

3 endpoints

Other/protocol endpoint

Change from baseline in fasting serum triglycerides

Time frame:Baseline up to 32 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other/protocol endpoint

Change from baseline in total cholesterol

Time frame:Baseline up to 32 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Other/protocol endpoint

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

Time frame:Baseline up to 32 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Concentration of apitegromab in circulation over time

Time frame:Baseline up to 40 weeks

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline up to 40 weeks

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

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

Time frame:Baseline up to 40 weeks

Immunogenicity (ADA)

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Concentration of latent myostatin in circulation over time

Time frame:Baseline up to 24 weeks

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Pratley RE, Denham DS, Trivedi R, Watkins E, Connery L, Barnes J, Yu D, Hong J, Simard C, Umans K, Liu L, Tirucherai GS, Marantz JL. Apitegromab for lean mass preservation during tirzepatide-induced weight loss: a randomized, double-blind, placebo-controlled phase 2 trial. Nat Med. 2026 Jun 8. doi: 10.1038/s41591-026-04440-4. Online ahead of print.
PMID42260100via clinicaltrials gov reference derived

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.