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Sponsor: Regeneron Pharmaceuticals
Conditions: Obesity
Interventions: Trevogrumab-Part A, Trevogrumab-Part B and Part C, Garetosmab, Semaglutide, Matching Placebo-Part A
Countries: United States, Puerto Rico
This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). This study will be done in 3 parts, Part A, Part B, and Part C where different study drugs will be tested. Part A of the study is focused on healthy participants. Part B and C of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B and Part C of the study is to see how safe and effective the study drug is when combined with Wegovy. Parts A, B, and C of the study are looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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
- Anniston, Alabama, United States
- Cullman, Alabama, United States
- Phoenix, Arizona, United States
- Anaheim, California, United States
- Chula Vista, California, United States
- Huntington Park, California, United States
- La Mesa, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Tarzana, California, United States
- Tarzana, California, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- Jacksonville, Florida, United States
- St. Petersburg, Florida, United States
- Sunrise, Florida, United States
- Tampa, Florida, United States
- Winter Haven, Florida, United States
- Gainesville, Georgia, United States
- Lawrenceville, Georgia, United States
- Woodstock, Georgia, United States
- Honolulu, Hawaii, United States
- Blackfoot, Idaho, United States
- Springfield, Illinois, United States
- South Bend, Indiana, United States
- Topeka, Kansas, United States
- Louisville, Kentucky, United States
- Marrero, Louisiana, United States
- Monroe, Louisiana, United States
- Rochester, Minnesota, United States
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