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This is a Phase I, randomized, double-blinded, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics (PK) of enicepatide in generally healthy adult Chinese participants with body mass index (BMI) ≥23.0 kilograms per meter squared (kg/m^2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enicepatide Dose 1 | Experimental |
| |
| Enicepatide Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enicepatide | Combination Product | Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events | Baseline to Safety Follow-Up (27 weeks) | |
| Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade | Baseline to Safety Follow-Up (27 weeks) | |
| Change from Baseline in Pulse Rate | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) | |
| Change from Baseline in Respiratory Rate | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) | |
| Change from Baseline in Systolic Blood Pressure | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) | |
| Change from Baseline in Diastolic Blood Pressure | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) | |
| Change from Baseline in Body Temperature | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Enicepatide | At prespecified time points from Day 1 to Day 190 | |
| Maximum Plasma Concentration Observed (Cmax) of Enicepatide | At prespecified time points from Day 1 to Day 190 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: YP46402 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | 100034 | China |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Placebo | Combination Product | Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol. |
|
| Time to Cmax (Tmax) of Enicepatide | At prespecified time points from Day 1 to Day 190 |
| Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of Enicepatide | At prespecified time points from Day 1 to Day 190 |
| Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide | At prespecified time points from Day 1 to Day 190 |
| Absolute Change From Baseline in Body Weight | Baseline through Week 24 |
| Percent Change From Baseline in Body Weight | Baseline through Week 24 |