Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07279194
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HDM1005 1 — DRUG
    Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total.
  • HDM1005 2 — DRUG
    Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.
  • Placebo — DRUG
    Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.

Study Details

This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.

Key Dates

First listed
Dec 12, 2025
Start date
Oct 14, 2025
Status verified
Nov 2025
Primary completion
Sep 20, 2026
Completion
Dec 13, 2026

Study Design

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

Arms

  • Experimental: HDM1005 Cohort 1
  • Experimental: HDM1005 Cohort 2
  • Placebo Comparator: Placebo

Primary Outcome Measure

primary outcome [ Time Frame: week 40 ]

Central Contacts

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