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

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Obesity & Overweight

Treatments: Drug: HDM1005 2; Drug: Placebo; Drug: HDM1005 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07279194

HDM1005-301

Details and patient eligibility

About

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.

Enrollment: 825 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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825 participants in 3 patient groups, including a placebo group

HDM1005 Cohort 1

Experimental group

Treatment:

Drug: HDM1005 1

HDM1005 Cohort 2

Experimental group

Treatment:

Drug: HDM1005 2

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo