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

NCT06500299 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: HDM1002-201
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity

Keywords

HDM1002 tablet; overweight and obesity; Glucagon-Like Peptide-1 Receptor Agonists

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12

  Baseline, Week 12

• Change From Baseline in Body Mass Index (BMI), And Waist Circumference

  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)

  Baseline, Week 12

• Change From Baseline in Systolic and Diastolic Blood Pressure

  Baseline, Week 12

Other Outcomes (9)

• Change From Baseline in Fasting Insulin

  Time Frame: Baseline, Week 12

• Change From Baseline in Fasting plasma Glucose

  Time Frame: Baseline, Week 12

• Change From Baseline in Fasting C-Peptide,

  Time Frame: Baseline, Week 12

Study Arms (4)

HDM1002 100mg BID

EXPERIMENTAL

HDM1002 tablets 100mg twice daily, 12weeks

Drug: HDM1002 100 mg QD

HDM1002 200mg BID

EXPERIMENTAL

HDM1002 tablets 200mg twice daily, 12weeks

Drug: HDM1002 200 mg QD 12weeks

HDM1002 400mg QD

EXPERIMENTAL

HDM1002 tablets 400mg once daily, 12weeks

Drug: HDM1002 400 mg QD 12weeks

placebo

PLACEBO COMPARATOR

Matching placebo will be provided， 12weeks

Drug: Placebo

Interventions

HDM1002 100 mg QD DRUG

HDM1002 tablets 100mg daily, 12weeks

Also known as: HDM1002

HDM1002 100mg BID

HDM1002 200 mg QD 12weeks DRUG

HDM1002 tablets 200mg daily, 12weeks

Also known as: HDM1002

HDM1002 200mg BID

HDM1002 400 mg QD 12weeks DRUG

HDM1002 tablets 400mg daily, 12weeks

Also known as: HDM1002

HDM1002 400mg QD

Placebo DRUG

Matching placebo will be provided

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Hypertension
• Impaired fasting glucose or impaired glucose tolerance
• Dyslipidemia
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoying Li

  Zhongshan Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenwen Tu

CONTACT

+86-0571-89903388; tuwenwen@eastchinapharm.com

Jing Liu

CONTACT

cxyliujing@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 15, 2024
• Study Start: July 15, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-05