Tests HDM1005 weekly in adults with obesity or overweight
Tests a once-weekly drug, HDM1005, against placebo in adults with excess weight.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of HDM1005 in Chinese Obesity or Overweight Patients Without Diabetes
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity, or with overweight and a weight-related health problem, who do not have diabetes. It tests HDM1005 against placebo.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- BMI 28 kg/m2 or higher, or BMI 24 kg/m2 or higher with at least one weight-related problem: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver or weight-bearing joint pain.
- Earlier treatment
- Cannot have used GLP-1 receptor drugs or similar combined drugs, or blood-sugar-lowering drugs, in the 3 months before screening.
Main reasons for not taking part
- Type 1 or type 2 diabetes, or HbA1c 6.5% (48 mmol/mol) or higher, or fasting blood glucose 7.0 mmol/L (126 mg/dL) or higher
- Weight change of more than 5% in the 90 days before screening
- History of thyroid C-cell cancer, MEN 2A or 2B, or pancreatitis
- Moderate to severe depression or severe mental illness
- Pregnant or breastfeeding, or not willing to use contraception
Read by machine on 9 November 2026.
Where in China
- Zhongshan HoapitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Trial code
- NCT07279194
- Record updated
- 12 December 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history; 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); Have type 1 diabetes mellitus (T1DM) or T2DM; Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine; History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history; Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past; 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; Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1; PHQ questionnaire ≥ 15 points at screening or randomization; 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.