Apitegromab for Obesity

(EMBRAZE Trial)

No longer recruiting at 6 trial locations

Overseen By Scholar Rock, Inc. Clinical Trials Administration

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Scholar Rock, Inc.

Must be taking: GLP-1 agonists

Disqualifiers: Cardiovascular, Neurovascular, Pulmonary, Diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called apitegromab to determine if it aids weight loss in individuals who are overweight or obese when combined with a GLP-1 receptor agonist. Participants will receive either apitegromab with this treatment or a placebo (a substance resembling the drug but without active ingredients) alongside the treatment. The goal is to determine if apitegromab enhances the effectiveness of the weight loss treatment. Individuals with stable body weight, a BMI of 30 or higher, or a BMI of 27 or higher with weight-related health issues, and no major chronic diseases may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant findings in weight loss therapy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves apitegromab as an additional therapy to GLP-1 agonist therapy, it might be best to discuss your current medications with the trial team.

Is there any evidence suggesting that apitegromab is likely to be safe for humans?

Research has shown that apitegromab, currently under study for obesity, holds promise in other areas as well. For instance, in studies involving individuals with spinal muscular atrophy (SMA), those treated with apitegromab demonstrated improved movement abilities over 48 months, suggesting it is well-tolerated over long periods.

In another study, apitegromab combined with tirzepatide helped patients maintain their lean muscle mass during treatment, indicating further evidence of its safety and tolerability.

While these results are encouraging, it is important to remember that all medications can have side effects. Ongoing research aims to better understand these effects. Always consult a healthcare provider before joining a study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard obesity treatments, which often focus on reducing appetite or calorie absorption, Apitegromab offers a novel approach by targeting myostatin, a protein that limits muscle growth. By inhibiting myostatin, Apitegromab may help increase muscle mass, potentially boosting metabolism and aiding weight loss. Researchers are excited about this treatment because it could offer a dual benefit: not only helping with weight reduction but also improving overall muscle health, which is crucial for long-term weight management.

What evidence suggests that apitegromab might be an effective treatment for obesity?

Research shows that apitegromab may help preserve muscle while supporting weight loss. In this trial, participants in Cohort 1 will receive apitegromab combined with an incretin mimetic. Previous studies have shown that patients using apitegromab with tirzepatide retained 54.9% more muscle, approximately 4.2 pounds, compared to those using tirzepatide alone. This combination could help maintain muscle while losing weight. Additionally, total weight loss was nearly the same between those on apitegromab-tirzepatide and tirzepatide alone, with only a small difference of about 1.1%. These findings suggest that apitegromab might effectively manage weight by preserving muscle mass. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or obese. It's not specified, but typically participants should be in stable health and willing to follow the study procedures. Details on specific inclusion and exclusion criteria are not provided.

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

My weight has been stable, within about 11 pounds, for the last 3 months.

My BMI is between 27 and 45, and I may have a weight-related health issue.

Exclusion Criteria

I haven't had immunosuppressive, chemotherapy, or radiation treatments in the last year.

I have a history of or currently have heart, brain, blood vessel, lung, liver, pancreas, muscle, or mental health issues.

I have cancer that is not just skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either apitegromab or placebo as an adjunctive therapy to GLP-1 agonist therapy for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Apitegromab

Trial Overview The trial is testing apitegromab as an additional treatment alongside GLP-1 agonist therapy (like Tirzepatide or Semaglutide) compared to a placebo, to see if it helps with weight loss in overweight or obese individuals.

How Is the Trial Designed?

Group I: Cohort 1 Experimental Treatment 2 Interventions

Apitegromab + incretin mimetic

Group II: Cohort 2 Placebo Group 2 Interventions

Placebo + incretin mimetic

Who Is Running the Clinical Trial?

Scholar Rock, Inc.

Lead Sponsor

Trials

7

Recruited

710+

Citations

1. investors.scholarrock.com investors.scholarrock.com/news-releases/news-release-details/scholar-rock-reports-positive-phase-2-embraze-trial-results

Scholar Rock Reports Positive Phase 2 EMBRAZE Trial ... Patients receiving apitegromab with tirzepatide over 24 weeks showed a 54.9% preservation of lean mass (+4.2 lbs of lean mass) versus ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06445075

NCT06445075 | Efficacy and Safety of Apitegromab for the ... 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.

3. finance.yahoo.com finance.yahoo.com/news/scholar-rock-reports-positive-phase-110000998.html

Scholar Rock Reports Positive Phase 2 EMBRAZE Trial ... Patients receiving apitegromab with tirzepatide over 24 weeks showed a 54.9% preservation of lean mass (+4.2 lbs of lean mass) versus ...

4. fiercebiotech.com fiercebiotech.com/biotech/scholar-rocks-sma-drug-helps-patients-zepbound-retain-muscle-phase-2-trial

Scholar Rock's SMA drug helps Zepbound patients retain ... When it came to total weight lost, patients on apitegromab-tirzepatide saw their weight drop by 12.3% compared to 13.4% for those on tirzepatide ...

5. firstwordpharma.com firstwordpharma.com/story/5986962

Scholar Rock Reports Second Quarter 2025 Financial ... Patients receiving apitegromab dosed at 10 mg/kg with tirzepatide over 24 weeks preserved an additional 4.2 pounds (1.9 kilograms) or 54.9% (p= ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8326894/

Preclinical Safety Assessment and Toxicokinetics of ... These data support the conduct of ongoing clinical studies of apitegromab in adult and pediatric patients with spinal muscular atrophy (SMA).

7. firstwordpharma.com firstwordpharma.com/story/5926188

Scholar Rock Highlights 2025 Strategic Priorities - Data from Phase 2 EMBRAZE trial evaluating apitegromab in obesity expected in 2Q 2025. - Filing of IND application for SRK-439 on track for ...

8. neurologylive.com neurologylive.com/view/muscle-targeting-therapy-apitegromab-effective-spinal-muscular-atrophy-over-4-year-period

Muscle-Targeting Therapy Apitegromab Effective in Spinal ... Scholar Rock's TOPAZ phase 2 trial shows sustained motor function improvements in SMA patients treated with apitegromab over 48 months.