Glucagon-Like Peptide-1 Receptor AgonistsPhase 1NCT06520540
HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects
A Phase 1 study testing HDM1002 100 mg QD 12weeks, HDM1002 200 mg QD 12weeks and HDM1002 400 mg QD 12weeks，Q 2W for titration in people with Glucagon-Like Peptide-1 Receptor Agonists, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To assess the safety of multiple oral doses of HDM1002 tablets under different titrations in Chinese overweight and obese adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucagon-Like Peptide-1 Receptor Agonists
- What is being tested?
- HDM1002 100 mg QD 12weeks, HDM1002 200 mg QD 12weeks and HDM1002 400 mg QD 12weeks，Q 2W for titration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2024to 30 Dec 2024
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;
- BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）；
- For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details);
- Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
Who cannot join
- Selection criteria:
- Subjects must meet all of the following inclusion criteria to be enrolled in this study:
- Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;
- BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）；
- For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details);
- Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
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- Subjects meeting either of the following criteria will be excluded:
- 5% self-reported or documented body weight change within 3 months prior to randomization;
- Previous diagnosis of type 1, type 2 or any other type of diabetes; or using hypoglycemic drugs; or HbA1c 6.5% at screening or fasting glucose 7.0 mmol/L; or fasting glucose <3.9 mmol / L;
- Diagnosis of overweight or obesity caused by other diseases or drugs;
- History or family history of medullary thyroid carcinoma, thyroid C cell hyperplasia, or multiple endocrine adenomatosis type 2;
- History of chronic pancreatitis or onset of acute pancreatitis within 3 months before signing an ICF;
- History of acute gallbladder disease within 3 months before signing the ICF;
- Any malignant tumor within 5 years before signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured);
- Combination of cardiovascular and cerebrovascular diseases with obvious clinical significance, including but not limited to angina pectoris, MI, stroke or severe peripheral artery circulation disorder within 1 year before signing ICF; presence of risk factors of torsade ventricular tachycardia; presence of untreated serious arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block; or screening systolic blood pressure 160 mmHg, or diastolic blood pressure 100 mmHg;
- In the judgment of the investigator, the subjects had some diseases or conditions that may affect drug absorption, such as active inflammatory bowel disease, gastrectomy resection, any intestinal area resection, etc.;
- Those who had major surgery within 3 months prior to signing the ICF or who performed surgery during the planned study;
- According to the investigator, the presence of concomitant diseases, including but not limited to the respiratory system, digestive system, nervous system, urogenital system, blood system, endocrine system and other diseases;
- Known intolerance or hypersensitivity to a GLP-1 receptor (GLP-1R) agonist;
- Within 3 months prior to ICF signing, the following drugs were used and significantly weight, including but not limited to: a. Drugs or products with weight loss effects, such as GLP-1R agonists (liraglutide, selmeaglutide, benallutide, etc.), orlistat, naltrexone / bupropion, etc.; b. Drugs or products that increase body weight, such as systemic corticosteroids, psychiatric medication (e. g., tricyclic antidepressants, paroxetine, olanzapine, clozapine, mirtazapine, valproic acid and its derivatives, etc.); c. Any Chinese patent medicine or Chinese herbal medicine that may affect the body weight;
- Any drug used within 14 days or may affect the pharmacokinetics of HDM1002 tablets (whichever is older) (see Section 6.4.2 and Section 6.4.3), including prescription drugs, over-the-counter drugs, Chinese herbal medicines, proprietary Chinese medicines, or nutritional supplements;
- Subjects taking lipid-lowering drugs within 30 days before signing ICF;
- Have participated in any clinical trial within 30 days before randomization or within 5 half-lives after the last dose (whichever is older) (except for signed ICF with no drug or device intervention);
- Any of the laboratory indicators during the screening period met the following criteria:
- <110 g / L for women and <120 g / L for men;
- glutamate aminotransferase> 2.0 upper limit of normal (ULN), or aminotransferase> 2.0 ULN, or alkaline phosphatase> 1.5 x ULN, or total bilirubin> 1.5 ULN (subjects with Gil bert's syndrome can participate in this study with direct bilirubin ULN);
- Triglycerides> 5.6 mmol / L;
- Calcitonin: 35 ng/L;
- Thyroid-stimulating hormone> 6.0 mIU / L or <0.4 mIU / L;
- Blood amylase or lipase> ULN;
- Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m, calculated from the Cooperative Epidemiological Study of Chronic Kidney Disease (CKD-EPI) formula2；
- The following ECG abnormalities were present during the screening period: QTcF> 450 ms, or heart rate <50 beats / min or> 100 beats / min;
- Positive test results for hepatitis B virus surface antigen, hepatitis C virus antibody or treponema pallidum antibody, or non-negative for human immunodeficiency virus;
- More than 5 cigarettes per day in the 3 months before signing the ICF;
- Those who had drunk alcohol abuse within 1 year before signing the ICF (i. e., drinking more than 14 standard units per week for men, women drinking more than 7 standard units per week, 1 standard unit containing 14 g alcohol, such as 360 ml beer or 150 ml alcohol of 40 ml), or prerandomized alcohol breath test or blood alcohol test positive;
- History of addictive drug abuse within 1 year before signing the ICF, or positive urine drug test before randomization;
- Within 7 days prior to randomization, subjects reported having consumed grapefruit or products containing grapefruit;
- Pregnancy (blood human chorionic gonadotropin 5 mIU / ml or positive urine pregnancy test) or lactating women;
- The subject is the investigator or other relevant investigator of the project;
- In the opinion of the investigator, the subject was not fit to participate in any other condition of the trial.
Trial locations and contacts
1 site in 1 country.
Jing liu contact
China1 site
HDM1002
Shanghai, Shanghai Municipality
kehui Wang, +86-0571-89903388, wangkehui@eastchinapharm.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Multiple Oral Administration of HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects
- To assess the safety of multiple oral doses of HDM1002 tablets under different titrations in Chinese overweight and obese adult subjects.
- Being tested
- HDM1002 100 mg QD 12weeks, HDM1002 200 mg QD 12weeks, HDM1002 400 mg QD 12weeks，Q 2W for titration, HDM1002 400 mg QD 12weeks，Q 3W for titration, Placebo
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, HDM1002 tablet, Chinese overweight and obese adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM1002 100 mg QD 12weeksDrug
Participants received maintenance dose of 100 mg HDM1002 administered orally once daily (QD)
HDM1002 200 mg QD 12weeksDrug
Participants received maintenance dose of 200 mg HDM1002 administered orally once daily (QD)
HDM1002 400 mg QD 12weeks，Q 2W for titrationDrug
Participants received maintenance dose of 400 mg HDM1002 administered orally once daily (QD) Q 2W for titration
HDM1002 400 mg QD 12weeks，Q 3W for titrationDrug
Participants received maintenance dose of 400 mg HDM1002 administered orally once daily (QD) Q 3W for titration
PlaceboDevice
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HDM1002 100 mg | Active comparator | Not described Receives: Drug: HDM1002 100 mg QD 12weeks; Drug: HDM1002 200 mg QD 12weeks; Drug: HDM1002 400 mg QD 12weeks，Q 2W for titration; Drug: HDM1002 400 mg QD 12weeks，Q 3W for titration |
| HDM1002 200 mg | Active comparator | Not described Receives: Drug: HDM1002 200 mg QD 12weeks; Drug: HDM1002 400 mg QD 12weeks，Q 2W for titration; Drug: HDM1002 400 mg QD 12weeks，Q 3W for titration |
| HDM1002 400 mg | Active comparator | Not described Receives: Drug: HDM1002 400 mg QD 12weeks，Q 2W for titration; Drug: HDM1002 400 mg QD 12weeks，Q 3W for titration |
| Placebo | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs, SAEs, AEs leading to withdrawal, and AEs leading to death, AEs of special interest
TEAEs and SAEs (incidence, severity and causal relationship), AEs leading to withdrawal, and AEs leading to death, AEs of special interest
Measured: Baseline, Week 12
Secondary outcomes (12)
change in body weight from baseline at Day 85
Weight during treatment from baseline
Measured: Baseline, Week 12
change in BMI from baseline at Day 85
change in body mass index (BMI) from baseline
Measured: Baseline, Week 12
change in waist circumference from baseline at Day 85
Change in waist circumference from baseline
Measured: Baseline, Week 12
Plasma PK parameters
Cmax
Measured: Baseline, Week 12
Plasma PK parameters
Tmax
Measured: Baseline, Week 12
Plasma PK parameters
AUC0-last
Measured: Baseline, Week 12
Plasma PK parameters
AUCtau
Measured: Baseline, Week 12
Plasma PK parameters
AUC0-24h
Measured: Baseline, Week 12
Plasma PK parameters
AUC0-∞
Measured: Baseline, Week 12
Plasma PK parameters
t1/2z
Measured: Baseline, Week 12
Plasma PK parameters
CL/F
Measured: Baseline, Week 12
Plasma PK parameters
Vz/F
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start28 Jul 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucagon-Like Peptide-1 Receptor AgonistsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 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
- NCT06520540
- Sponsor's protocol ID
- HDM1002-103
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Multiple Oral Administration of HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects
- ClinicalTrials.gov ID
- NCT06520540
- Acronym / sponsor ID
- HDM1002-103
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, HDM1002 tablet, Chinese overweight and obese adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 25 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.
- To assess the safety of multiple oral doses of HDM1002 tablets under different titrations in Chinese overweight and obese adult subjects.
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 100 mg | Active comparator | Drug: HDM1002 100 mg QD 12weeks, Drug: HDM1002 200 mg QD 12weeks, Drug: HDM1002 400 mg QD 12weeks，Q 2W for titration, Drug: HDM1002 400 mg QD 12weeks，Q 3W for titration |
| HDM1002 200 mg | Active comparator | Drug: HDM1002 200 mg QD 12weeks, Drug: HDM1002 400 mg QD 12weeks，Q 2W for titration, Drug: HDM1002 400 mg QD 12weeks，Q 3W for titration |
| HDM1002 400 mg | Active comparator | Drug: HDM1002 400 mg QD 12weeks，Q 2W for titration, Drug: HDM1002 400 mg QD 12weeks，Q 3W for titration |
| Placebo | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;
- BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）；
- For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details);
- Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
Key exclusion criteria (40 listed)
- Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;
- BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）；
- For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details);
- Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
- 5% self-reported or documented body weight change within 3 months prior to randomization;
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 QD 12weeksParticipants received maintenance dose of 100 mg HDM1002 administered orally once daily (QD) | Drug | HDM1002 100 mg |
| HDM1002 200 mg QD 12weeksParticipants received maintenance dose of 200 mg HDM1002 administered orally once daily (QD) | Drug | HDM1002 100 mg, HDM1002 200 mg |
| HDM1002 400 mg QD 12weeks，Q 2W for titrationParticipants received maintenance dose of 400 mg HDM1002 administered orally once daily (QD) Q 2W for titration | Drug | HDM1002 100 mg, HDM1002 200 mg, HDM1002 400 mg |
| HDM1002 400 mg QD 12weeks，Q 3W for titrationParticipants received maintenance dose of 400 mg HDM1002 administered orally once daily (QD) Q 3W for titration | Drug | HDM1002 100 mg, HDM1002 200 mg, HDM1002 400 mg |
| PlaceboPlacebo | Device | Placebo |
Primary outcome
TEAEs, SAEs, AEs leading to withdrawal, and AEs leading to death, AEs of special interest
Time frame: Baseline, Week 12
TEAEs and SAEs (incidence, severity and causal relationship), AEs leading to withdrawal, and AEs leading to death, AEs of special interest
12 secondary outcomes
change in body weight from baseline at Day 85
Time frame: Baseline, Week 12
change in BMI from baseline at Day 85
Time frame: Baseline, Week 12
change in waist circumference from baseline at Day 85
Time frame: Baseline, Week 12
Plasma PK parameters
Time frame: Baseline, Week 12
Plasma PK parameters
Time frame: Baseline, Week 12
Plasma PK parameters
Time frame: Baseline, Week 12
Plasma PK parameters
Time frame: Baseline, Week 12
Plasma PK parameters
Time frame: Baseline, Week 12
Plasma PK parameters
Time frame: Baseline, Week 12
Plasma PK parameters
Time frame: Baseline, Week 12
Plasma PK parameters
Time frame: Baseline, Week 12
Plasma PK parameters
Time frame: Baseline, Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HDM1002 100 mg QD 12weeks, HDM1002 200 mg QD 12weeks and HDM1002 400 mg QD 12weeks，Q 2W for titration in people with Glucagon-Like Peptide-1 Receptor Agonists, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
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 4 inclusion and 40 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 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
TEAEs, SAEs, AEs leading to withdrawal, and AEs leading to death, AEs of special interest (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 25 Jul 2024.