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NCT Number: NCT07626515

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University First Hospital

Beijing, 100034, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enicepatide

Combination Product

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

Other names: RO7795068, CT-388, RG6640

Placebo

Combination Product

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

Primary outcomes

  1. Incidence and Severity of Adverse Events

    Time frame: Baseline to Safety Follow-Up (27 weeks)

  2. Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade

    Time frame: Baseline to Safety Follow-Up (27 weeks)

  3. Change from Baseline in Pulse Rate

    Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

  4. Change from Baseline in Respiratory Rate

    Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

  5. Change from Baseline in Systolic Blood Pressure

    Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

  6. Change from Baseline in Diastolic Blood Pressure

    Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

  7. Change from Baseline in Body Temperature

    Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)

Secondary outcomes

  1. Plasma Concentration of Enicepatide

    Time frame: At prespecified time points from Day 1 to Day 190

  2. Maximum Plasma Concentration Observed (Cmax) of Enicepatide

    Time frame: At prespecified time points from Day 1 to Day 190

  3. Time to Cmax (Tmax) of Enicepatide

    Time frame: At prespecified time points from Day 1 to Day 190

  4. Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of Enicepatide

    Time frame: At prespecified time points from Day 1 to Day 190

  5. Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide

    Time frame: At prespecified time points from Day 1 to Day 190

  6. Absolute Change From Baseline in Body Weight

    Time frame: Baseline through Week 24

  7. Percent Change From Baseline in Body Weight

    Time frame: Baseline through Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: YP46402 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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