Testing new drugs for weight loss in adults with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of experimental drugs trevogrumab and garetosmab, in combination with semaglutide, for weight loss in adults with obesity. The study is divided into three parts: Part A focuses on healthy participants to assess safety and tolerability, while Parts B and C involve participants with obesity to evaluate the drugs' effectiveness. Researchers will also monitor side effects, drug levels in the blood, and the body's immune response to the drugs. The study aims to provide insights into new treatment options for obesity.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

Part A

1. Male or female participants age ≥18 to ≤55 years of age at the time of screening
2. BMI ≥18 and ≤32 kg/m2, at the screening visit

   Part B and Part C
3. Male or female participants ≥18 to ≤80 years of age at the time of screening
4. BMI ≥30 kg/m2, at the screening visit
5. History of 1 or more self-reported unsuccessful dietary attempts to lose weight

Key Exclusion Criteria

1. History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
2. Previous bariatric surgery or planned bariatric surgery
3. History of hypertrophic cardiomyopathy
4. Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy
5. Any malignancy in the past 5 years prior to screening (except for nonmelanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years prior to screening)
6. History of poorly controlled hypertension, as defined in the protocol
7. Have a history of any other condition (such as known drug abuse, alcohol abuse, diagnosed eating disorder, or a severe mental illness) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
8. Have history of use of marijuana/tetrahydrocannabinol (THC) within 90 days prior to Visit 1 of enrollment and are unwilling to abstain from marijuana/THC use during the trial
9. Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc)

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Where it's running

• Pinnacle Research Group
  Anniston, Alabama, United States Recruiting
• Cullman Clinical Trials
  Cullman, Alabama, United States Recruiting
• Foothills Research Center Cct Research
  Phoenix, Arizona, United States Recruiting
• Anaheim Clinical Trials
  Anaheim, California, United States Recruiting
• ProSciento
  Chula Vista, California, United States Recruiting
• Valiance Clinical Research- Huntington Park
  Huntington Park, California, United States Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.