Clinical trial NCT06500299: Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Overweight and Obesity
Keywords: HDM1002 tablet
overweight and obesity
Glucagon-Like Peptide-1 Receptor Agonists
Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage Change From Baseline in Body Weight at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage Change From Baseline in Body Weight at Week 2, Week 4, Week 6, Week 8, Week 10
timeFrame: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10
measure: Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Body Mass Index (BMI), And Waist Circumference
timeFrame: Baseline, Week 12
measure: 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)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Systolic and Diastolic Blood Pressure
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Through Week 16]
Other outcomes:
measure: Change From Baseline in Fasting Insulin
timeFrame: Time Frame: Baseline, Week 12
measure: Change From Baseline in Fasting plasma Glucose
timeFrame: Time Frame: Baseline, Week 12
measure: Change From Baseline in Fasting C-Peptide,
timeFrame: Time Frame: Baseline, Week 12
measure: Change From Baseline in HbA1c at Week 12
timeFrame: Time Frame: Baseline, Week 12
measure: Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)
timeFrame: Day 1, Day 15, Day 29, Day 57 and Day 85
measure: Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)
timeFrame: Day 1, Day 15, Day 29, Day 57 and Day 85
measure: Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)
timeFrame: Day 1, Day 15, Day 29, Day 57 and Day 85
measure: Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)
timeFrame: Day 1, Day 15, Day 29, Day 57 and Day 85
measure: Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)
timeFrame: Day 1, Day 15, Day 29, Day 57 and Day 85
Locations:
Study officials:
affiliation: Zhongshan Hospital, Shanghai, China
name: Xiaoying Li
role: PRINCIPAL_INVESTIGATOR
References: