Apitegromab for Obesity

(EMBRAZE Trial)

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

100 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight or obesity

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Cohort 1 Experimental Treatment 3 Interventions

Apitegromab + incretin mimetic

Group II: Cohort 2 Placebo Group 3 Interventions

Placebo + incretin mimetic

Who Is Running the Clinical Trial?

Scholar Rock, Inc.

Lead Sponsor

Trials

7

Recruited

710+