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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHoffmann-La Roche

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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/m² at screening

Agreement to adhere to the contraception requirements

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RO7795081

    Drug

    RO7795081 will be administered orally once a day.

  • Placebo

    Drug

    Placebo will be administered orally once a day.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: RO7795081Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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)

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

Other outcomes

Sponsors and contacts

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