Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT04440345
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Overweight or Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IBI362 — DRUG
    Administered by subcutaneous injection
  • Placebo — DRUG
    Administered by subcutaneous injection

Study Details

This trial is conducted in China. The aim of this trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of IBI362 in Overweight or Obese Male and Female Subjects.

Key Dates

Start date
Jun 16, 2020
Status verified
Nov 2023
Primary completion
Jun 16, 2021
Completion
Aug 6, 2021

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI362
    Participants received dose 1 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 2 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 3 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 4 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 5 level of IBI362 administered as multiple subcutaneous doses.
  • Placebo Comparator: placebo
    Participants received matching placebo dose regiments by subcutaneous injection

Primary Outcome Measure

Number of treatment adverse events [ Time Frame: From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week) ]

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