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NCT Number: NCT07499050

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

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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Key information

Conditions

Healthy Volunteers Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nanjing Gulou Hospital, Nanjing, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RO7795081

Drug

RO7795081 will be administered orally once a day.

Other names: CT-996, RG6652

Placebo

Drug

Placebo will be administered orally once a day.

Primary outcomes

  1. Incidence, Severity, and Causal Relationship to Treatment of Adverse Events

    Time frame: Baseline to Safety Follow-Up (26 weeks)

  2. Incidence of Abnormal Clinical Laboratory Test Findings

    Time frame: Baseline to Safety Follow-Up (26 weeks)

  3. Incidence of Abnormal Vital Signs

    Time frame: Baseline to Safety Follow-Up (26 weeks)

  4. Incidence of Abnormal Electrocardiogram (ECG) Results

    Time frame: Baseline to Safety Follow-Up (26 weeks)

  5. Incidence of Abnormal Psychiatry Parameters

    Time frame: 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 outcomes

  1. Plasma Concentration of RO7795081

    Time frame: At prespecified timepoints on Weeks 8, 14, 17, 19, 21, and 22

  2. Maximum Plasma Concentration Observed (Cmax) of RO7795081

    Time frame: At prespecified timepoints on Weeks 8, 14, and 22

  3. Time to Cmax (Tmax) of RO7795081

    Time frame: At prespecified timepoints on Weeks 8, 14, and 22

  4. Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of RO7795081

    Time frame: At prespecified timepoints on Weeks 8, 14, and 22

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: YP46260 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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