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Testing new drugs for weight loss in adults with obesity

A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity

Phase 2 Interventional Regeneron Pharmaceuticals · NCT06299098

This study is testing new weight loss drugs, trevogrumab and garetosmab, along with semaglutide, to see if they can help adults with obesity lose weight safely and effectively.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment999 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionstrevogrumab, garetosmab
Locations61 sites (Anniston, Alabama and 60 other locations)
Trial IDNCT06299098 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with a BMI of 30 or higher and a history of unsuccessful weight loss attempts.

Not a fit: Patients with a history of diabetes or those who have undergone bariatric surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer new effective treatments for weight loss in adults with obesity.

How similar studies have performed: Other studies have shown promise with similar drug combinations for obesity treatment, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Anniston, Alabama and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityObesity without diabetesQuality of weight lossFat mass lossLean mass loss
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.