Overweight and Obesity
Conditions
Keywords
HDM1002 tablet, overweight and obesity, Glucagon-Like Peptide-1 Receptor Agonists
Brief summary
It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults.
Detailed description
This multicenter, randomized, double-blind, placebo-controlled phase II clinical trial aims to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults. Participants with a BMI between 24 and 40 will be include. A total of 180 participants will be randomized in a 1:1:1:1 ratio to receive different doses of HDM1002 or placebo. Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a treatment period will be 12 weeks, followed by an approximate 4-week follow-up.
Interventions
DRUGHDM1002 100 mg QD
HDM1002 tablets 100mg daily, 12weeks
HDM1002 tablets 200mg daily, 12weeks
DRUGHDM1002 400 mg QD 12weeks
HDM1002 tablets 400mg daily, 12weeks
DRUGPlacebo
Matching placebo will be provided
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects between 18 and 65 years of age (inclusive). * BMI≥28 but \< 40.0 kg/m2 at screening or randomization，or BMI≥24.0 kg/m2 but \< 28 kg/m2 with any of the following: 1. Hypertension 2. Impaired fasting glucose or impaired glucose tolerance 3. Dyslipidemia 4. Obstructive sleep apnea syndrome * At least one previous failure to lose weight through lifestyle modification was defined as \< 5% weight loss after ≥3 months of lifestyle modification.
Exclusion criteria
* Weight change ≥5% as reported or documented. Previous diagnosis of type 1, type 2, or any other type of diabetes. * Diagnosis of overweight or obesity due to other diseases or medications. * History or family history of medullary thyroid carcinoma, C cell hyperplasia, or multiple endocrine neoplasia type 2. * Have diseases or conditions that affect gastric emptying or gastrointestinal absorption of nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, chronic pancreatitis, etc. Or a history of acute pancreatitis or acute gallbladder disease within 3 months before signing ICF. * GLP-1R agonist use within 6 months prior to signing ICF. * Use of hypoglycemic drugs within 3 months before signing ICF.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Body Weight at Week 12 | Baseline, Week 12 | Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12 | Baseline, Week 12 | Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg. |
| Percentage Change From Baseline in Body Weight at Week 2, Week 4, Week 6, Week 8, Week 10 | Baseline, Week 2, Week 4, Week 6, Week 8, Week 10 | Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg. |
| Change From Baseline in Body Mass Index (BMI), And Waist Circumference | Baseline, Week 12 | BMI was recorded in kg/m2, and Waist Circumference was recorded in cm |
| Percentage change from baseline in fasting lipid profile (total cholesterol, low density lipoprotein [LDL] cholesterol, high density lipoprotein [HDL] cholesterol, non HDL cholesterol, lipoprotein (a) (Lp[a]), triglycerides) | Baseline, Week 12 | Fasting Lipid Profiles were measured at planned time points. |
| Change From Baseline in Systolic and Diastolic Blood Pressure | Baseline, Week 12 | Blood Pressure was measured using an automated device |
| Number of Participants with Clinical Laboratory Abnormalities, and Abnormalities in Vital Signs, Physical Examination and Electrocardiogram and Number of Participants With Treatment Emergent Adverse Events | Through Week 16] | Vital signs (blood pressure, pulse rate, body temperature, respiratory rate), physical examination, ECG and clinical laboratory evaluations (hematology, clinical chemistry, coagulation, urinalysis, calcitonin, serum amylase and lipase) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting C-Peptide, | Time Frame: Baseline, Week 12 | The fasting plasma glucose measures the levels of C-Peptide were measured at planned time points |
| Change From Baseline in HbA1c at Week 12 | Time Frame: Baseline, Week 12 | HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control |
| Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible) | Day 1, Day 15, Day 29, Day 57 and Day 85 | Area under the curve from time 0 to 24 h(AUC0-24h) |
| Change From Baseline in Fasting plasma Glucose | Time Frame: Baseline, Week 12 | The fasting plasma glucose measures the levels of glucose in the bloodFasting Insulin were measured at planned time points |
| Change From Baseline in Fasting Insulin | Time Frame: Baseline, Week 12 | The fasting plasma glucose measures the levels of Fasting Insulin were measured at planned time points |
Contacts
Primary ContactWenwen Tu
Backup ContactJing Liu
Outcome results
None listed