Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Cohort | Experimental |
| |
| Subgroup Cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olatorepatide | Drug | Administered per the protocol |
|
| Measure | Description | 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 |
| Measure | Description | 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 | |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research - Flourish Research | Walnut Creek | California | 94598 | United States | ||
| Clinical Site Partners, LLC DBA Flourish Research |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered per the protocol |
|
| 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 |
| Winter Park |
| Florida |
| 32789 |
| United States |
| Flourish Research - San Antonio Medical Trials | San Antonio | Texas | 78229 | United States |
| D013568 | Pathological Conditions, Signs and Symptoms |