Actively Recruiting
An Investigator- and Participant-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase I Study Evaluating Multiple Doses of Orally Administered RO7795081 in Healthy Chinese Adults With Obesity or Overweight
Led by Hoffmann-La Roche · Updated on 2026-06-08
30
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of the drug RO7795081 taken by mouth in healthy Chinese adults who are overweight or have obesity. This Phase I study is randomized, placebo-controlled, and both the participants and investigators are blinded to the treatment assignments, aiming to understand how the drug behaves and its effects in this population. Participants will be randomly assigned to receive either RO7795081 or a placebo, both administered orally once daily. The study includes a treatment period followed by safety follow-up lasting up to 26 weeks. The design allows comparison between the active drug and placebo to assess safety and bodily responses over time. During the study, participants will undergo medical evaluations including physical exams, laboratory tests, cardiac monitoring, and assessments of vital signs and psychiatric parameters. Blood samples will be taken at specific weeks to measure drug levels and pharmacokinetic parameters. Researchers will monitor any adverse events and abnormal test results from the start through the safety follow-up period, ensuring thorough safety surveillance throughout participation.
CONDITIONS
Brief Title
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who are healthy based on medical evaluation including medical history, physical exam, lab tests, and cardiac monitoring
- Ethnically Chinese participants living in mainland China
- Body mass index (BMI) of 24 kg/m² or higher at screening
- Agreement to follow contraception requirements
You will not qualify if you...
- Any medical condition expected to progress, recur, or change significantly that could bias clinical or mental status assessment or pose special risk
- Clinically significant impaired endocrine, thyroid, liver, lung, or kidney function
- Unstable or insulin-dependent diabetes mellitus
- Significant cardiovascular disease
- Pheochromocytoma
- History of any psychotic mental illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 22 weeks
Participants receive multiple doses of the study drug or placebo orally once a day.
Weekly visits for up to 22 weeks
Duration - 4 weeks
Participants are monitored for safety and adverse events after treatment ends.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Nanjing Gulou Hospital
Nanjing, China
Actively Recruiting
2
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China, 200003
Actively Recruiting
Research Team
R
Reference Study ID Number: YP46260 https://forpatients.roche.com/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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