A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

Sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Study ID
NCT07243171
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Overweight and/or Obesity
  • Weight Management

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • ecnoglutide tablets — DRUG
    oral tablets
  • placebo with matching dosage — DRUG
    oral tablets

Study Details

The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity

Key Dates

Start date
Nov 18, 2025
Status verified
Oct 2025
Primary completion
Aug 3, 2026
Completion
Nov 22, 2026

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: oral ecnoglutide dose 1
    once daily
  • Experimental: oral ecnoglutide dose 2
    once daily
  • Experimental: oral ecnoglutide dose 3
    once weekly
  • Experimental: oral ecnoglutide dose 4
    once weekly
  • Placebo Comparator: placebo dose 1
    once daily
  • Placebo Comparator: placebo dose 2
    once weekly

Primary Outcome Measure

The incidence and severity of adverse events [ Time Frame: up to day 204 ]

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