RecruitingPhase 1NCT07499050

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

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


Sponsor

Hoffmann-La Roche

Enrollment

30 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria1

  • 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.

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Interventions

DRUGRO7795081

RO7795081 will be administered orally once a day.

DRUGPlacebo

Placebo will be administered orally once a day.


Locations(2)

Nanjing Gulou Hospital

Nanjing, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

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NCT07499050


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