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Apitegromab for Obesity (EMBRAZE Trial)

Phase 2
Recruiting
Research Sponsored by Scholar Rock, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, age ≥ 18 and ≤ 65 years at the time of informed consent
Be older than 18 years old
Must not have
History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to Screening
History of or active cardiovascular, neurovascular, peripheral vascular, pulmonary, hepatic, pancreatic, neuromuscular, and/or psychiatric disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 40 weeks
Awards & highlights

Summary

"This trial is testing the effects of apitegromab when used alongside another type of therapy in people who are overweight or obese."

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, common ones for weight loss drugs can include gastrointestinal issues like nausea, diarrhea, constipation; potential low blood sugar; and possible injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had immunosuppressive, chemotherapy, or radiation treatments in the last year.
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I have a history of or currently have heart, brain, blood vessel, lung, liver, pancreas, muscle, or mental health issues.
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I have cancer that is not just skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 40 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 40 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in total Lean Body Mass (kg) at 24 weeks
Secondary outcome measures
Change from Baseline in body weight
Change from Baseline in fat body mass (kg and %)
Change from Baseline in percent lean body mass (%)
+7 more
Other outcome measures
Change from Baseline in HbA1c
Change from baseline in fasting serum triglycerides
Change from baseline in low-density lipoprotein cholesterol (LDL-C)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 1Experimental Treatment3 Interventions
Apitegromab + incretin mimetic
Group II: Cohort 2Placebo Group3 Interventions
Placebo + incretin mimetic
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160
Tirzepatide
2019
Completed Phase 3
~5560

Find a Location

Who is running the clinical trial?

Scholar Rock, Inc.Lead Sponsor
5 Previous Clinical Trials
632 Total Patients Enrolled
~67 spots leftby Jun 2025
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