Obesity
Conditions
Keywords
Obesity without diabetes, Quality of weight loss, Fat mass loss, Lean mass loss
Brief 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)
Detailed description
Part A Healthy Volunteers Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity
Interventions
DRUGTrevogrumab-Part A
Administered IV or SC in Part A
DRUGTrevogrumab-Part B and Part C
Administered SC in Part B, Part C
DRUGGaretosmab
Administered IV in Part B
DRUGSemaglutide
Administered SC in Part B and Part C
DRUGMatching Placebo-Part A
Administered IV or SC in Part A
DRUGMatching Placebo-Trevogrumab
Administered SC in Part B and Part C
DRUGMatching Placebo-Garetosmab
Administered IV in Part B
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Baseline to week 7 | Part A |
| Severity of TEAEs | Baseline to week 7 | Part A |
| Percent change in total fat mass | Baseline to week 26 | Part B |
| Percent change in total lean mass | Baseline to week 26 | Part B |
| Percent change in body weight | Baseline to week 26 | Part B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of trevogrumab in serum over time | Up to 75 weeks | Part A, Part B, and Part C |
| Percent change in total fat mass | Baseline to week 52 | Part B |
| Percent change in total lean mass | Baseline to week 52 | Part B |
| Percent change in body weight | Baseline to week 52 | Part B |
| Change in waist circumference (cm) | Baseline to week 26 | Part B and Part C |
| Percent change in fasting serum triglycerides | Baseline to week 26 | Part B |
| Percent change in total cholesterol | Baseline to week 26 | Part B |
| Percent change in Apolipoprotein B (Apo B) | Baseline to week 26 | Part B |
| Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline to week 26 | Part B |
| Concentrations of garetosmab in serum over time | Up to 75 weeks | Part B |
| Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time | Up to 75 weeks | Part B and Part C |
| Magnitude of ADAs to trevogrumab over time | Up to 75 weeks | Part B and Part C |
| Incidence of ADAs to garetosmab after repeated doses over time | Up to 75 weeks | Part B |
| Magnitude of ADAs to garetosmab over time | Up to 75 weeks | Part B |
| Incidence of TEAEs | Up to 75 weeks | Part B and Part C |
| Severity of TEAEs | Up to 75 weeks | Part B and Part C |
| Concentration of total Growth Differentiation Factor (GDF) 8 in serum over time | Up to 75 weeks | Part C |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed