Healthy Volunteers, Overweight or Obesity
Conditions
Brief summary
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.
Interventions
DRUGRO7795081
RO7795081 will be administered orally once a day.
DRUGPlacebo
Placebo will be administered orally once a day.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * Participants who are ethnically Chinese and living in mainland China * Body mass index (BMI) ≥24 kg/m\^2 at screening * Agreement to adhere to the contraception requirements
Exclusion criteria
* Any medical condition or disease that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the participant to a significant degree or put the participant at special risk in the opinion of the Investigator. Such conditions may include clinically significantly impaired endocrine, thyroid, hepatic, respiratory, or renal function for any reason, unstable diabetes mellitus and insulin dependent diabetes mellitus, clinically significant cardiovascular disease, pheochromocytoma, or history of any psychotic mental illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to Safety Follow-Up (26 weeks) | 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. |
Secondary
| Measure | 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 |
| 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 |
Contacts
CONTACTReference Study ID Number: YP46260 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed