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

July 11, 2024 updated by: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in Body Weight at Week 12
Time Frame: Baseline, Week 12
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Systolic and Diastolic Blood Pressure
Time Frame: Baseline, Week 12
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
Time Frame: 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.
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10
Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12
Time Frame: Baseline, 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
Time Frame: Baseline, Week 12
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)
Time Frame: Baseline, Week 12
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
Time Frame: 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)
Through Week 16]

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Insulin
Time Frame: Time Frame: Baseline, Week 12
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
Time Frame: Time Frame: Baseline, Week 12
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,
Time Frame: Time Frame: Baseline, Week 12
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
Time Frame: 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
Time Frame: Baseline, Week 12
Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)
Time Frame: Day 1, Day 15, Day 29, Day 57 and Day 85
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)
Time Frame: Day 1, Day 15, Day 29, Day 57 and Day 85
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)
Time Frame: Day 1, Day 15, Day 29, Day 57 and Day 85
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 Frame: Day 1, Day 15, Day 29, Day 57 and Day 85
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)
Time Frame: Day 1, Day 15, Day 29, Day 57 and Day 85
AUCtau
Day 1, Day 15, Day 29, Day 57 and Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaoying Li, Zhongshan Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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