Healthy ParticipantsPhase 1NCT07626515
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Enicepatide in Generally Healthy Adult Chinese Participants
A Phase 1 study testing Enicepatide in people with Healthy Participants, run by Hoffmann-La Roche at 1 site in China.
Trial summary
This is a Phase I, randomized, double-blinded, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics (PK) of enicepatide in generally healthy adult Chinese participants with body mass index (BMI) ≥23.0 kilograms per meter squared (kg/m^2). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Enicepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2026to 14 May 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
- No evidence of active or chronic disease as determined by detailed medical and surgical history and the results of a physical examination, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests
- BMI ≥23 kg/m^2 at screening
- Agreement to adhere to the contraception requirements
Who cannot join
- History of acute or chronic pancreatitis
- History of clinically significant gallbladder disease in the opinion of the investigator
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
- History or presence of an abnormal ECG that is deemed clinically significant in the opinion of the investigator
- Clinically significant abnormalities (as judged by the investigator) in laboratory test results
- History or presence of clinically significant cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, pulmonary disease, or history of any of these diseases with renal, hepatic, or cardiopulmonary dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: YP46402 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
About this study
Official title: A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Enicepatide in Adult Chinese Participants With Body Mass Index ≥23.0 kg/m2
This is a Phase I, randomized, double-blinded, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics (PK) of enicepatide in generally healthy adult Chinese participants with body mass index (BMI) ≥23.0 kilograms per meter squared (kg/m^2).
- Conditions
- Healthy Participants
- Being tested
- Enicepatide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnicepatideCombination product
Also called RO7795068, CT-388, RG6640
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
PlaceboCombination product
Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Enicepatide Dose 1 | Experimental | Not described Receives: Combination Product: Enicepatide |
| Enicepatide Dose 2 | Experimental | Not described Receives: Combination Product: Enicepatide |
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events
Measured: Baseline to Safety Follow-Up (27 weeks)
Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade
Measured: Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Pulse Rate
Measured: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Respiratory Rate
Measured: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Systolic Blood Pressure
Measured: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Diastolic Blood Pressure
Measured: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Change from Baseline in Body Temperature
Measured: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
Secondary outcomes (7)
Plasma Concentration of Enicepatide
Measured: At prespecified time points from Day 1 to Day 190
Maximum Plasma Concentration Observed (Cmax) of Enicepatide
Measured: At prespecified time points from Day 1 to Day 190
Time to Cmax (Tmax) of Enicepatide
Measured: At prespecified time points from Day 1 to Day 190
Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of Enicepatide
Measured: At prespecified time points from Day 1 to Day 190
Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide
Measured: At prespecified time points from Day 1 to Day 190
Absolute Change From Baseline in Body Weight
Measured: Baseline through Week 24
Percent Change From Baseline in Body Weight
Measured: Baseline through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start2 Jul 2026
- Primary completion14 May 2027 (estimated)
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 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
- NCT07626515
- Sponsor's protocol ID
- YP46402
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No