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

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

Recruiting
18-65 years
All
Phase 1

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Overview

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

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 details
    Healthy Participants

NCT07626515

Hoffmann-La Roche

11 July 2026

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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