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Recruiting NCT07279194

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

Phase III Interventional Obesity & Overweight

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: HDM1005 1, HDM1005 2, Placebo.
Who it may be relevant to
Registry conditions: Obesity & Overweight. Basic parameters: from 18 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

Efficacy and Safety of HDM1005 Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial

Overview

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.

Interventions

  • Drug HDM1005 1
    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.
  • Drug HDM1005 2
    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.
  • Drug Placebo
    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.

Primary outcome measures

  • primary outcome [Time frame: week 40]
  • Co-primary outcome [Time frame: week 40]
Secondary outcome measures (8)
  • secondary outcome [Time frame: week 40]
  • secondary outcome [Time frame: week 40]
  • secondary outcome [Time frame: week 52]
  • secondary outcome [Time frame: week 40]
  • secondary outcome [Time frame: week 52]
  • safety outcome [Time frame: week 52]
  • patient report outcome [Time frame: week 52]
  • Immunogenicity outcome [Time frame: week 52]

Eligibility criteria

Inclusion criteria

  • Male or female, aged ≥18 years at the time of signing informed consent.
  • BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint pain.
  • A self-reported change in body weight no more than 5% within 90 days before screening.
  • Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.

Exclusion criteria

  • Have type 1 diabetes mellitus (T1DM) or T2DM.
  • Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1.
  • Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
  • Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months prior to screening.
  • Use of hypoglycemic drugs within 3 months prior to screening.
  • History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history.
  • Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history.
  • PHQ questionnaire ≥ 15 points at screening or randomization.
  • Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past.
  • Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs).
  • History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.
  • History of severe cardiovascular or cerebrovascular diseases within the past six months.
  • History of alcohol and drug abuse at screening.
  • The participant may be allergic to ingredients in the study drug or drugs of the same class.
  • Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study.
  • The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hoapital — Shanghai

Identifiers

NCT: NCT07279194 · HDM1005-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗