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

NCT07626515

RecruitingPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Healthy Participants

Interventions: Enicepatide, Placebo

Countries: China

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Beijing, China