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Recruiting NCT07499050

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

Phase I Interventional Healthy Volunteers Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RO7795081, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers, Overweight or Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Drug RO7795081
    RO7795081 will be administered orally once a day.
  • Drug Placebo
    Placebo will be administered orally once a day.

Primary outcome measures

  • Incidence, Severity, and Causal Relationship to Treatment of Adverse Events [Time frame: Baseline to Safety Follow-Up (26 weeks)]
  • Incidence of Abnormal Clinical Laboratory Test Findings [Time frame: Baseline to Safety Follow-Up (26 weeks)]
  • Incidence of Abnormal Vital Signs [Time frame: Baseline to Safety Follow-Up (26 weeks)]
  • Incidence of Abnormal Electrocardiogram (ECG) Results [Time frame: Baseline to Safety Follow-Up (26 weeks)]
  • Incidence of Abnormal Psychiatry Parameters [Time frame: Baseline to Safety Follow-Up (26 weeks)]
Secondary outcome measures (4)
  • Plasma Concentration of RO7795081 [Time frame: At prespecified timepoints on Weeks 8, 14, 17, 19, 21, and 22]
  • Maximum Plasma Concentration Observed (Cmax) of RO7795081 [Time frame: At prespecified timepoints on Weeks 8, 14, and 22]
  • Time to Cmax (Tmax) of RO7795081 [Time frame: 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 [Time frame: At prespecified timepoints on Weeks 8, 14, and 22]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

China · 2 centers
  • Nanjing Gulou Hospital — Nanjing
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai

Identifiers

NCT: NCT07499050 · YP46260

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗