Overweight or Obesity
Conditions
Keywords
Body weight, Waist circumference, Glucagon-Like Peptide-1 (GLP-1) receptor agonist, Control appetite, Glucose-dependent Insulinotropic Polypeptide (GIP)
Brief summary
This study will test olatorepatide (study drug) to determine how safe and effective this drug is and how easily your body can accept this drug without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity. The study will test how safe and effective the study drug works compared to placebo in people who are overweight or obese but do not have diabetes. The study is looking at: * What side effects the study drug might cause * How much the study drug is in the blood at different times * How well the study drug works * If the body makes antibodies to the study drug as this may cause the study drug to not work as well
Interventions
DRUGOlatorepatide
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Body mass index ≥27.0 kg/m\^2 to \<45.0 kg/m\^2 at screening 2. Demonstrates ability and willingness to comply with the study protocol, including attending all scheduled visits, adhering to the prescribed treatment regimen, and completing all required assessment Key
Exclusion criteria
1. History of Type 1 or Type 2 diabetes 2. Change in body weight \>5 kg within approximately 3 months before screening as described in the protocol 3. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions, prior to randomization or planned during the study period 4. History of any of the following conditions: acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones or has a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years as described in the protocol Note: Other Protocol Defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 30 weeks |
| Severity of TEAEs | Up to approximately 30 weeks |
| Maximum plasma Concentration (Cmax) | At week 15 and week 24 |
| Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h) | At week 15 and week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in body weight | From baseline to week 25 |
| Change in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) | From baseline to weeks 7, 15 and 24 |
| Change in in-clinic SBP | From baseline to weeks 7, 15 and 24 |
| Lowest concentration in a dosing interval (Ctrough) | Up to approximately 30 weeks |
| Time to Cmax (Tmax) | Up to approximately 30 weeks |
| Apparent Volume of distribution (Vd/F) | Up to approximately 30 weeks |
| Apparent clearance (CL/F) | Up to approximately 30 weeks |
| Apparent terminal half-life (t½) | Up to approximately 30 weeks |
| Olatorepatide concentrations | Up to approximately 30 weeks |
| Occurrence of Anti-Drug Antibody (ADA) to olatorepatide | Up to approximately 30 weeks |
| Magnitude of ADA to olatorepatide | Up to approximately 30 weeks |
| Corrected QT interval using the Fridericia formula (QTcF) | Pre-dose to up to 48 hours post-dose |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed