A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Enicepatide in Generally Healthy Adult Chinese Participants

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Combination product: Enicepatide; Combination product: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
• Study Contact Backup: Name: Reference Study ID Number: YP46402 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Combination product: Placebo; Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol.
Experimental: Enicepatide Dose 1	Combination product: Enicepatide; Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.; Other Names: RO7795068; RG6640; CT-388
Experimental: Enicepatide Dose 2	Combination product: Enicepatide; Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.; Other Names: RO7795068; RG6640; CT-388

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide	At prespecified time points from Day 1 to Day 190
Absolute Change From Baseline in Body Weight	Baseline through Week 24
Percent Change From Baseline in Body Weight	Baseline through Week 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 26, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: YP46402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No