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• To assess the safety of multiple oral doses of HDM1002 tablets under different titrations in Chinese overweight and obese adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM1002 100 mg | Active Comparator |
| |
| HDM1002 200 mg | Active Comparator |
| |
| HDM1002 400 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM1002 100 mg QD 12weeks | Drug | Participants received maintenance dose of 100 mg HDM1002 administered orally once daily (QD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| change in body weight from baseline at Day 85 | Weight during treatment from baseline | Baseline, Week 12 |
| change in BMI from baseline at Day 85 | change in body mass index (BMI) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
Selection criteria:
Subjects must meet all of the following inclusion criteria to be enrolled in this study:
Exclusion criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenwen Tu | Contact | +86-0571-89903388 | tuwenwen@eastchinapharm.com | |
| Jing liu | Contact | cxyliujing@eastchinapharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoying Li | Zhongshan Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HDM1002 | Shanghai | Shanghai Municipality | China |
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| HDM1002 200 mg QD 12weeks | Drug | Participants received maintenance dose of 200 mg HDM1002 administered orally once daily (QD) |
|
| HDM1002 400 mg QD 12weeks,Q 2W for titration | Drug | 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 titration | Drug | Participants received maintenance dose of 400 mg HDM1002 administered orally once daily (QD) Q 3W for titration |
|
| Placebo | Device | Placebo |
|
| Baseline, Week 12 |
| change in waist circumference from baseline at Day 85 | Change in waist circumference from baseline | Baseline, Week 12 |
| Plasma PK parameters | Cmax | Baseline, Week 12 |
| Plasma PK parameters | Tmax | Baseline, Week 12 |
| Plasma PK parameters | AUC0-last | Baseline, Week 12 |
| Plasma PK parameters | AUCtau | Baseline, Week 12 |
| Plasma PK parameters | AUC0-24h | Baseline, Week 12 |
| Plasma PK parameters | AUC0-∞ | Baseline, Week 12 |
| Plasma PK parameters | t1/2z | Baseline, Week 12 |
| Plasma PK parameters | CL/F | Baseline, Week 12 |
| Plasma PK parameters | Vz/F | Baseline, Week 12 |