HDM1005 for Obesity or Overweight in Chinese Participants
HDM1005 1
+ HDM1005 2
+ Placebo
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: October 14, 2025
Actual date on which the first participant was enrolled.This study focuses on evaluating a medication called HDM1005 for people in China who are overweight or have obesity, but do not have type 2 diabetes. The aim is to determine how effective and safe HDM1005 is when taken once a week. Participants in this study may also have other health issues related to their weight. The goal is to find out if HDM1005 can help reduce body weight, which is important because excess weight can lead to various health problems. Addressing weight issues might help improve overall health and reduce the risk of related diseases. In this study, participants will be randomly assigned to receive either different doses of HDM1005 or a placebo, which is a substance with no active medication, in a 1:1:1 ratio. This will be done once a week for 52 weeks. Additionally, all participants will receive support in the form of diet and exercise counseling to encourage a healthy lifestyle. Researchers will measure the outcomes by looking at how much participants' body weight changes over 40 weeks, specifically checking if there's a reduction of at least 5% in body weight. This measurement will help determine the effectiveness of the treatment. After the 52 weeks of treatment, there will be a 4-week period to monitor safety.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.825 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Male or female, aged ≥18 years at the time of signing informed consent. 2. 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. 3. A self-reported change in body weight no more than 5% within 90 days before screening. 4. 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: 1. Have type 1 diabetes mellitus (T1DM) or T2DM. 2. Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1. 3. Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine. 4. 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. 5. Use of hypoglycemic drugs within 3 months prior to screening. 6. History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history. 7. Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history. 8. PHQ questionnaire ≥ 15 points at screening or randomization. 9. Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past. 10. 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). 11. History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening. 12. History of severe cardiovascular or cerebrovascular diseases within the past six months. 13. History of alcohol and drug abuse at screening. 14. The participant may be allergic to ingredients in the study drug or drugs of the same class. 15. Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study. 16. 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location