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This study will test an experimental drug called olatorepatide ("study drug") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes.
The study is looking at:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olatorepatide arm 1 | Experimental |
| |
| Olatorepatide arm 2 | Experimental |
| |
| Olatorepatide arm 3 | Experimental |
| |
| Olatorepatide arm 4 | Experimental |
| |
| Olatorepatide arm 5 | Experimental |
| |
| Matching Placebo arm 6 | Active Comparator |
|
| 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 60 weeks | |
| Severity of TEAEs | Up to approximately 60 weeks | |
| Percent change in body weight | From baseline to week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Olatorepatide concentrations | Up to approximately 60 weeks | |
| Occurrence of Anti-Drug Antibody (ADA) to olatorepatide | Up to approximately 52 weeks | |
| Magnitude of ADA to olatorepatide |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
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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
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| 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 |
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|
| Placebo | Drug | Administered per the protocol |
|
| Up to approximately 52 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |