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This is an investigator- and participant-blind, randomized, placebo-controlled, parallel-group, Phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of orally administered RO7795081 in otherwise healthy Chinese adult participants with obesity or overweight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7795081 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7795081 | Drug | RO7795081 will be administered orally once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, Severity, and Causal Relationship to Treatment of Adverse Events | Baseline to Safety Follow-Up (26 weeks) | |
| Incidence of Abnormal Clinical Laboratory Test Findings | Baseline to Safety Follow-Up (26 weeks) | |
| Incidence of Abnormal Vital Signs | Baseline to Safety Follow-Up (26 weeks) | |
| Incidence of Abnormal Electrocardiogram (ECG) Results | Baseline to Safety Follow-Up (26 weeks) | |
| Incidence of Abnormal Psychiatry Parameters | Participants with psychiatric abnormalities include those with a Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at any assessment, any suicidal behavior, or any suicidal ideation of Type 4 (active suicidal ideation with some intent to act without a specific plan) or Type 5 (active suicidal ideation with a specific plan and intent) on any Columbia-Suicide Severity Rating Scale (C-SSRS) assessment. | Baseline to Safety Follow-Up (26 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of RO7795081 | At prespecified timepoints on Weeks 8, 14, 17, 19, 21, and 22 | |
| Maximum Plasma Concentration Observed (Cmax) of RO7795081 | At prespecified timepoints on Weeks 8, 14, and 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: YP46260 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 |
|---|---|---|---|---|---|---|
| Nanjing Gulou Hospital | Recruiting | Nanjing | China | |||
| Ruijin Hospital Shanghai Jiaotong University School of Medicine |
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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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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Drug | Placebo will be administered orally once a day. |
|
| Time to Cmax (Tmax) of RO7795081 | At prespecified timepoints on Weeks 8, 14, and 22 |
| Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of RO7795081 | At prespecified timepoints on Weeks 8, 14, and 22 |
| Recruiting |
| Shanghai |
| 200003 |
| China |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |