A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe… (NCT06299098) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss, Fat Loss, and Lean Mass Preservation
United States1,005 participantsStarted 2024-03-13
Plain-language summary
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)
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female participants age ≥18 to ≤55 years of age at the time of screening
✓. BMI ≥18 and ≤32 kg/m2, at the screening visit
✓. Male or female participants ≥18 to ≤80 years of age at the time of screening
✓. BMI ≥30 kg/m2, at the screening visit
✓. History of 1 or more self-reported unsuccessful dietary attempts to lose weight
Exclusion criteria
✕. History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
✕. Previous bariatric surgery or planned bariatric surgery
✕. History of hypertrophic cardiomyopathy
✕. Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy
✕. 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)
What they're measuring
1
Incidence of treatment-emergent adverse events (TEAEs)
✕. History of poorly controlled hypertension, as defined in the protocol
✕. 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
✕. 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