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Recruiting NCT07626515

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

Phase I Interventional Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enicepatide, Placebo.
Who it may be relevant to
Registry conditions: Healthy Participants. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

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).

Interventions

  • Combination product Enicepatide
    Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
  • Combination product Placebo
    Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol.

Primary outcome measures

  • Incidence and Severity of Adverse Events [Time frame: 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 [Time frame: Baseline to Safety Follow-Up (27 weeks)]
  • Change from Baseline in Pulse Rate [Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)]
  • Change from Baseline in Respiratory Rate [Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)]
  • Change from Baseline in Systolic Blood Pressure [Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)]
  • Change from Baseline in Diastolic Blood Pressure [Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)]
  • Change from Baseline in Body Temperature [Time frame: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)]
Secondary outcome measures (7)
  • Plasma Concentration of Enicepatide [Time frame: At prespecified time points from Day 1 to Day 190]
  • Maximum Plasma Concentration Observed (Cmax) of Enicepatide [Time frame: At prespecified time points from Day 1 to Day 190]
  • Time to Cmax (Tmax) of Enicepatide [Time frame: 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 [Time frame: At prespecified time points from Day 1 to Day 190]
  • Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide [Time frame: At prespecified time points from Day 1 to Day 190]
  • Absolute Change From Baseline in Body Weight [Time frame: Baseline through Week 24]
  • Percent Change From Baseline in Body Weight [Time frame: Baseline through Week 24]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT07626515 · YP46402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗