Healthy VolunteersPhase 1NCT07499050
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
A Phase 1 study testing RO7795081 in people with Healthy Volunteers and Overweight or Obesity, run by Hoffmann-La Roche at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Overweight or Obesity
- What is being tested?
- RO7795081
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 30 Mar 2026to 9 Jan 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites
Nanjing Gulou Hospital
Nanjing
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200003
About this study
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
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.
- Conditions
- Healthy Volunteers, Overweight or Obesity
- Being tested
- RO7795081, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7795081Drug
Also called CT-996, RG6652
RO7795081 will be administered orally once a day.
PlaceboDrug
Placebo will be administered orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| RO7795081 | Experimental | Not described Receives: Drug: RO7795081 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, Severity, and Causal Relationship to Treatment of Adverse Events
Measured: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Clinical Laboratory Test Findings
Measured: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Vital Signs
Measured: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Electrocardiogram (ECG) Results
Measured: Baseline to Safety Follow-Up (26 weeks)
Incidence of Abnormal Psychiatry Parameters
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.
Measured: Baseline to Safety Follow-Up (26 weeks)
Secondary outcomes (4)
Plasma Concentration of RO7795081
Measured: At prespecified timepoints on Weeks 8, 14, 17, 19, 21, and 22
Maximum Plasma Concentration Observed (Cmax) of RO7795081
Measured: At prespecified timepoints on Weeks 8, 14, and 22
Time to Cmax (Tmax) of RO7795081
Measured: 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
Measured: At prespecified timepoints on Weeks 8, 14, and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start30 Mar 2026
- Primary completion9 Jan 2027 (estimated)
- Study completion9 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499050
- Sponsor's protocol ID
- YP46260
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No