Overweight and ObesityPhase 2NCT06500299
Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
A Phase 2 study testing HDM1002 100 mg QD, HDM1002 200 mg QD 12weeks and HDM1002 400 mg QD 12weeks in people with Overweight and Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- HDM1002 100 mg QD, HDM1002 200 mg QD 12weeks and HDM1002 400 mg QD 12weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 30 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Jing Liu contact
About this study
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
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- HDM1002 100 mg QD, HDM1002 200 mg QD 12weeks, HDM1002 400 mg QD 12weeks, Placebo
- Keywords
- HDM1002 tablet, overweight and obesity, Glucagon-Like Peptide-1 Receptor Agonists
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1002 100 mg QDDrug
Also called HDM1002
HDM1002 tablets 100mg daily, 12weeks
HDM1002 200 mg QD 12weeksDrug
Also called HDM1002
HDM1002 tablets 200mg daily, 12weeks
HDM1002 400 mg QD 12weeksDrug
Also called HDM1002
HDM1002 tablets 400mg daily, 12weeks
PlaceboDrug
Matching placebo will be provided
| Study group | Role | What they receive |
|---|---|---|
| HDM1002 100mg BID | Experimental | HDM1002 tablets 100mg twice daily, 12weeks Receives: Drug: HDM1002 100 mg QD |
| HDM1002 200mg BID | Experimental | HDM1002 tablets 200mg twice daily, 12weeks Receives: Drug: HDM1002 200 mg QD 12weeks |
| HDM1002 400mg QD | Experimental | HDM1002 tablets 400mg once daily, 12weeks Receives: Drug: HDM1002 400 mg QD 12weeks |
| placebo | Placebo comparator | Matching placebo will be provided， 12weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Body Weight at Week 12
Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg.
Measured: Baseline, Week 12
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, Week 12
Change From Baseline in Systolic and Diastolic Blood Pressure
Blood Pressure was measured using an automated device
Measured: 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)
Measured: Through Week 16]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoying Li, Principal investigator, Zhongshan Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500299
- Sponsor's protocol ID
- HDM1002-201
- Status last verified
- May 2024
- First submitted
- 13 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06500299
- Acronym / sponsor ID
- HDM1002-201
- Conditions
- Overweight and Obesity
- Keywords
- HDM1002 tablet, overweight and obesity, Glucagon-Like Peptide-1 Receptor Agonists
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HDM1002 100mg BID | Experimental | Drug: HDM1002 100 mg QDHDM1002 tablets 100mg twice daily, 12weeks |
| HDM1002 200mg BID | Experimental | Drug: HDM1002 200 mg QD 12weeksHDM1002 tablets 200mg twice daily, 12weeks |
| HDM1002 400mg QD | Experimental | Drug: HDM1002 400 mg QD 12weeksHDM1002 tablets 400mg once daily, 12weeks |
| placebo | Placebo comparator | Drug: PlaceboMatching placebo will be provided， 12weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- At least one previous failure to lose weight through lifestyle modification was defined as < 5% weight loss after ≥3 months of lifestyle modification.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDM1002 100 mg QDAlso: HDM1002HDM1002 tablets 100mg daily, 12weeks | Drug | HDM1002 100mg BID |
| HDM1002 200 mg QD 12weeksAlso: HDM1002HDM1002 tablets 200mg daily, 12weeks | Drug | HDM1002 200mg BID |
| HDM1002 400 mg QD 12weeksAlso: HDM1002HDM1002 tablets 400mg daily, 12weeks | Drug | HDM1002 400mg QD |
| PlaceboMatching placebo will be provided | Drug | placebo |
Primary outcome
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.
6 secondary outcomes
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
Percentage Change of Participants Achieving Weight Loss ≥ 5% and ≥ 10% at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Body Mass Index (BMI), And Waist Circumference
Time frame: 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
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: 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]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Liu contact
Xiaoying Li principal investigator
Zhongshan Hospital, Shanghai, China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDM1002 100 mg QD, HDM1002 200 mg QD 12weeks and HDM1002 400 mg QD 12weeks in people with Overweight and Obesity, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenwen Tu (+86-0571-89903388, tuwenwen@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change From Baseline in Body Weight at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.