Obesity & Overweight
Conditions
Brief summary
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
DRUGHDM1005 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.
DRUGHDM1005 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.
DRUGPlacebo
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.
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary outcome | week 40 | The percentage change in body weight from baseline to week 40 |
| Co-primary outcome | week 40 | Proportion of subjects with body weight reduction ≥ 5% at Week 40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| secondary outcome | week 40 | The proportion of participants reaching a body weight loss of at least 10% and 15% at week 40 |
| safety outcome | week 52 | the incidence of adverse events |
| patient report outcome | week 52 | 36-Item Short Form Health Survey, Version 2 questionnaire (scores range from 0 to 100, with higher scores indicating better health status) after administration for 52 weeks. |
| Immunogenicity outcome | week 52 | ADA and NAb |
Countries
China
Contacts
Primary ContactHui Qiao
Outcome results
None listed