Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Drug: Placebo; Drug: HDM1002 100 mg QD; Drug: HDM1002 200 mg QD 12weeks; Drug: HDM1002 400 mg QD 12weeks

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wenwen Tu; Phone Number: +86-0571-89903388; Email: tuwenwen@eastchinapharm.com
• Study Contact Backup: Name: Jing liu; Email: cxyliujing@eastchinapharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HDM1002 100mg BID; HDM1002 tablets 100mg twice daily, 12weeks	Drug: HDM1002 100 mg QD; HDM1002 tablets 100mg daily, 12weeks; Other Names: HDM1002
Experimental: HDM1002 200mg BID; HDM1002 tablets 200mg twice daily, 12weeks	Drug: HDM1002 200 mg QD 12weeks; HDM1002 tablets 200mg daily, 12weeks; Other Names: HDM1002
Experimental: HDM1002 400mg QD; HDM1002 tablets 400mg once daily, 12weeks	Drug: HDM1002 400 mg QD 12weeks; HDM1002 tablets 400mg daily, 12weeks; Other Names: HDM1002
Placebo Comparator: placebo; Matching placebo will be provided， 12weeks	Drug: Placebo; Matching placebo will be provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change From Baseline in Body Weight at Week 12	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Systolic and Diastolic Blood Pressure	Blood Pressure was measured using an automated device	Baseline, Week 12
Percentage Change From Baseline in Body Weight at Week 2, Week 4, Week 6, Week 8, Week 10	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.	Baseline, Week 2, Week 4, Week 6, Week 8, Week 10
Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12	Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.	Baseline, Week 12
Change From Baseline in Body Mass Index (BMI), And Waist Circumference	BMI was recorded in kg/m2, and Waist Circumference was recorded in cm	Baseline, Week 12
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)	Fasting Lipid Profiles were measured at planned time points.	Baseline, Week 12
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	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)	Through Week 16]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fasting Insulin	The fasting plasma glucose measures the levels of Fasting Insulin were measured at planned time points	Time Frame: Baseline, Week 12
Change From Baseline in Fasting plasma Glucose	The fasting plasma glucose measures the levels of glucose in the bloodFasting Insulin were measured at planned time points	Time Frame: Baseline, Week 12
Change From Baseline in Fasting C-Peptide,	The fasting plasma glucose measures the levels of C-Peptide were measured at planned time points	Time Frame: Baseline, Week 12
Change From Baseline in HbA1c at Week 12	HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control	Time Frame: Baseline, Week 12
Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)	Area under the curve from time 0 to 24 h(AUC0-24h)	Day 1, Day 15, Day 29, Day 57 and Day 85
Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)	Maximum plasma concentration (Cmax),	Day 1, Day 15, Day 29, Day 57 and Day 85
Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)	Minumum plasma concentration (Cmin)	Day 1, Day 15, Day 29, Day 57 and Day 85
Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)	Time to maximum plasma concentration (Tmax)	Day 1, Day 15, Day 29, Day 57 and Day 85
Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)	AUCtau	Day 1, Day 15, Day 29, Day 57 and Day 85

Collaborators and Investigators

• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Xiaoying Li, Zhongshan Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: overweight and obesity; Glucagon-Like Peptide-1 Receptor Agonists; HDM1002 tablet
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: HDM1002-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No