A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight

NCT07499050 | Recruiting Phase 1

• 1 other identifier: YP46260
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteers; Overweight or Obesity

Outcome Measures

Primary Outcomes (5)

• 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)

Secondary Outcomes (4)

• 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

Study Arms (2)

RO7795081

EXPERIMENTAL

Drug: RO7795081

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

RO7795081 DRUG

RO7795081 will be administered orally once a day.

Also known as: CT-996, RG6652

RO7795081

Placebo DRUG

Placebo will be administered orally once a day.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Nanjing Gulou Hospital

Nanjing, China

RECRUITING

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200003, China

RECRUITING

Related Links

• 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.

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 30, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)