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
- Are there results?
- Not yet: the study is under way
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
- Nov 2026
- First submitted
- 23 Mar 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07499050
- Acronym / sponsor ID
- YP46260
- Conditions
- Healthy Volunteers, Overweight or Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 9 Jan 2027 (estimated)
- Study completion
- 9 Jan 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RO7795081 | Experimental | Drug: RO7795081 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7795081Also: CT-996, RG6652RO7795081 will be administered orally once a day. | Drug | RO7795081 |
| PlaceboPlacebo will be administered orally once a day. | Drug | Placebo |
Primary outcome
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.
4 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, Severity, and Causal Relationship to Treatment of Adverse Events (time frame: Baseline to Safety Follow-Up (26 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.