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

NCT07499050 — Phase 1, Active not recruiting, 30 participants, Hoffmann-La Roche

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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

RegistryNCT07499050
StatusActive not recruiting
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: double, basic science
Enrollment30 (Estimated)
SponsorHoffmann-La Roche (Industry)
ConditionsHealthy Volunteers, Overweight or Obesity
InterventionsRO7795081, Placebo (Drug)
Datesstart 2026-03-30, primary completion 2027-01-09 (estimated), completion 2027-01-09 (estimated), first posted 2026-03-30, last updated 2026-08-10
Locations2 sites in China

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Volunteers All trials for Overweight or Obesity All trials of RO7795081 All trials of Placebo

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
RO7795081ExperimentalDrug: RO7795081
PlaceboPlacebo comparatorDrug: Placebo
  • RO7795081 (Drug), also known as CT-996, RG6652: RO7795081 will be administered orally once a day.
  • Placebo (Drug): Placebo will be administered orally once a day.

+Outcome measures

Primary outcomes

  • 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 [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

  • 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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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.

+Locations (2)

FacilityCityCountryStatus
Nanjing Gulou HospitalNanjingChina
Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghaiChina

+Investigators

  • Clinical Trials, Study director, Hoffmann-La Roche