---
title: A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
nct_id: NCT07499050
overall_status: RECRUITING
phase: PHASE1
sponsor: Hoffmann-La Roche
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07499050.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07499050"
ct_last_update_post_date: 2026-05-07
last_seen_at: "2026-05-12T06:04:05.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight

**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

**NCT ID:** [NCT07499050](https://clinicaltrials.gov/study/NCT07499050)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Hoffmann-La Roche
- **Conditions:** Healthy Volunteers, Overweight or Obesity
- **Start Date:** 2026-03-30
- **Completion Date:** 2026-12-29
- **CT.gov Last Update:** 2026-05-07

## Brief 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

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **RO7795081** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **RO7795081** (DRUG) — RO7795081 will be administered orally once a day.
- **Placebo** (DRUG) — Placebo will be administered orally once a day.

## Primary Outcomes

- **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))_ — 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** _(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)_

## Locations (2)

- Nanjing Gulou Hospital, Nanjing, China — _RECRUITING_
- Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.nanjing gulou hospital|nanjing||china` — added _(2026-05-12)_
- `locations.ruijin hospital shanghai jiaotong university school of medicine|shanghai||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07499050.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07499050*  
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