Weight control in T2DM, overweight and obese people
Conditions
Interventions
Group 1 :HDM1005 injection (dosage 1)/placebo
Group 2:HDM1005 injection (dosage 2)/placebo
Group 3:HDM1005 injection (dosage 3)/placebo
Group 4:HDM1005 injection (dosage 4)/placebo
Group 5:HDM1005 injection (dosage 5)/placebo
Group 6:HDM1005 injection (dosage 6)/placebo
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Chinese subjects aged 18-55 years (inclusive of 18 years and 55 years), either male or female; 2. BMI between 19.0 and 32.0 kg/m2 (including 19.0 and 32.0 kg/m2), female subjects weighing =45 kg and male subjects weighing =50 kg at screening; 3. Vital signs, physical examination, laboratory tests, 12-lead ECG, and chest imaging during the screening period are normal or abnormal without clinical significance; 4. Female subjects of childbearing potential who have used and agree to continue to use highly effective contraception from 14 days prior to signing the ICF to 2 months after the administration of the drug, and have no plans for childbearing or egg donation; male subjects who have no plans for childbearing or sperm donation from the signing of the ICF to 4 months after the administration of the drug, and who agree to use highly effective contraception; 5. Able to understand the procedures and methods of this study, sign the ICF voluntarily, and willing to strictly abide by the requirements of the clinical trial protocol to complete the relevant processes.
Exclusion criteria
Exclusion criteria: 1. A previous diagnosis of type 1, type 2, or other type of diabetes mellitus; 2. A history or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2; 3. A combination of diseases or conditions that, in the judgement of the Investigator, interfere with gastric emptying or absorption of nutrients from the gastrointestinal tract, such as bariatric or other gastric resection, irritable bowel syndrome, dyspepsia, or history of chronic pancreatitis; or a history of acute pancreatitis or acute gallbladder disease within 3 months prior to signing up for the ICF; 4. Any malignant tumour within 5 years prior to signing the ICF (except basal cell carcinoma which has received curative treatment and is considered cured); 5. Angina pectoris, myocardial infarction, ischaemic stroke, coronary artery bypass grafting or percutaneous coronary intervention within 1 year prior to signing the ICF; the presence of untreated severe cardiac arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block; 6. The coexistence of obvious or clinically significant diseases/abnormalities, including but not limited to cardiovascular, respiratory, digestive, neurological, genitourinary, haematological, and endocrine systems; 7. Those who have undergone major surgery within 3 months prior to signing the ICF or those who are scheduled to undergo surgery during the study; 8. Known allergy to any component of the study drug or previous history of severe drug allergy; 9. Use of the following medications within 3 months prior to signing up for the ICF that, as determined by the investigator, significantly affect body weight, including but not limited to: a. medications or products that have a weight-reducing effect, e.g., GLP-1R agonists (liraglutide, simethicone, beheneruptide, etc.), orlistat, naltrexone/bupropion, etc.; and b. weight-gaining medications or products, such as systemic glucocorticosteroids, medications for psychiatric disorders (e.g. tricyclic antidepressants, paroxetine, olanzapine, clozapine, mirtazapine, valproic acid and its derivatives, etc.); c. Any proprietary Chinese medicines or herbal medicines, etc., which may affect body weight; 10. Use of glucose-lowering medication within 3 months prior to signing the ICF that significantly affects blood glucose as determined by the investigator; 11. Use within 14 days or 5 half-lives (whichever is longer) prior to randomisation of any prescription, over-the-counter, herbal, proprietary Chinese medicine, or nutritional supplement that may: a. potentially affect the pharmacokinetic profile of HDM1005 injection; b. be subject to a delay in gastric emptying that interferes with absorption; c. known to prolong the QTc interval; and d. any drug that has an effect on the evaluation of PK, PD indicator evaluations; and d. any drug that has an effect on the evaluation of PK, PD 12. Participation in any clinical trial within 30 days prior to randomisation or within 5 half-lives of the last dose of the investigational drug in the clinical trial in which they are participating, whichever is longer (except for ICF-only signatories who have not received a drug or device intervention); 13. Meet the following criteria for any of the ancillary tests during the Screening Period: a) AST > 1.5x Upper Limit of Normal (ULN) or AST > 1.5x ULN or Alkaline Phosphatase > 1.5x ULN or Total Bilirubin > 1.5x ULN (subjects with Gilbert's Syndr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome;PD outcome; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed