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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHoffmann-La Roche

About this trial

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 criteria

Qualifiers

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/m² at screening

Agreement to adhere to the contraception requirements

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Enicepatide
  • Placebo

Treatment groups

36 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators