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

Trial statusRecruiting
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Enicepatide

    Combination product

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

  • Placebo

    Combination product

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

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Enicepatide Dose 1Experimental treatment 1 intervention
Group B: Enicepatide Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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)

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

Other outcomes

Sponsors and contacts

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