Healthy Participants
Conditions
Brief 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).
Interventions
COMBINATION_PRODUCTEnicepatide
Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
COMBINATION_PRODUCTPlacebo
Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Diastolic Blood Pressure | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) |
| Change from Baseline in Body Temperature | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) |
| Incidence and Severity of Adverse Events | 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 | Baseline to Safety Follow-Up (27 weeks) |
| Change from Baseline in Pulse Rate | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) |
| Change from Baseline in Respiratory Rate | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) |
| Change from Baseline in Systolic Blood Pressure | At prespecified time points from Baseline to Safety Follow-Up (27 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide | At prespecified time points from Day 1 to Day 190 |
| Percent Change From Baseline in Body Weight | Baseline through Week 24 |
| Plasma Concentration of Enicepatide | At prespecified time points from Day 1 to Day 190 |
| Maximum Plasma Concentration Observed (Cmax) of Enicepatide | At prespecified time points from Day 1 to Day 190 |
| Time to Cmax (Tmax) of Enicepatide | 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 | At prespecified time points from Day 1 to Day 190 |
| Absolute Change From Baseline in Body Weight | Baseline through Week 24 |
Countries
China
Contacts
CONTACTReference Study ID Number: YP46402 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed