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

NCT07626515 | Not Yet Recruiting Phase 1

• 1 other identifier: YP46402
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• 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

Study Arms (3)

Enicepatide Dose 1

EXPERIMENTAL

Combination Product: Enicepatide

Enicepatide Dose 2

EXPERIMENTAL

Combination Product: Enicepatide

Placebo

PLACEBO COMPARATOR

Combination Product: Placebo

Interventions

Enicepatide COMBINATION_PRODUCT

Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.

Also known as: RO7795068, CT-388, RG6640

Enicepatide Dose 1; Enicepatide Dose 2

Placebo COMBINATION_PRODUCT

Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Related 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 Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: YP46402 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): June 26, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share