Overweight, obesity, type 2 diabetes
Conditions
Interventions
Group 1 (Part A: SAD):HEC-007 injection 0.1 mg, single abdominal subcutaneous dose on D1 under fasting conditions
all 4 subjects receive HEC-007
Group 2 (Part A: SAD):HEC-007 injection 0.3 mg, single abdominal subcutaneous dose on D1 under fasting conditions
8 subjects receive HEC-007 and 2 receive placebo
Group 3 (Part A: SAD):HEC-007 injection 1 mg, single abdominal subcutaneous dose on D1 under fasting conditions
Group 4 (Part A: SAD):HEC-007 injection 3 mg, single abdominal subcutaneous dose on D1 under fasting conditions
Group 5 (Part A: SAD):HEC-007 injection 6 mg, single abdominal subcutaneous dose on D1 under fasting conditions
Group 6 (Part A: SAD):HEC-007 injection 9 mg, single abdominal subcutaneous dose on D1 under fasting conditions
Group 7 (Part B: MAD):HEC-007 injection 1 mg once weekly from W1 to W12 for 12 weeks by abdominal subcutaneous injection
10 subjects receive HEC-007 and 2 receive placebo
Group 8 (Part B: MAD):HEC-007 injection 3 mg once weekly from W1 to W12 for 12 weeks by abdominal subcutaneous injection
Group 9 (Part B: MAD):HEC-007 injection 3/6 mg dose escalation: 3 mg for 4 weeks followed by 6 mg for 8 weeks
once weekly from W1 to W12 for 12 weeks by abdominal subcutaneous injection
Group 10 (Part B: MAD):HEC-007 injection 3/6/9 mg dose escalation: 3 mg for 4 weeks, followed by 6 mg for 4 weeks, followed by 9 mg for 4 weeks
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. SAD1: The subject understands and complies with the research procedures, participates voluntarily, and signs the informed consent form; 2. SAD2: Healthy adult subjects aged 18 to 45 inclusive, of either sex; 3. SAD3: Male subjects must weigh no less than 50kg, female subjects no less than 45kg. Body Mass Index (BMI) = weight (kg) / height^2 (m^2), with BMI falling within the range of 19.0 to 35.0 kg/m^2 (including boundary values); 4. SAD4: Vital signs, physical examination, laboratory tests, and results of electrocardiogram, chest CT scan, abdominal ultrasound (liver, gallbladder, spleen, pancreas, both kidneys), thyroid ultrasound, etc., were normal or deemed by the investigator to be abnormal but without clinical significance; 5. SAD5: Female subjects with potential fertility or male subjects must agree to use effective contraception from the date of signing the informed consent form until 6 months after the last dose of the investigational medicinal product, to avoid pregnancy or causing pregnancy in their partner, and must have no plans for sperm donation, egg donation, or pregnancy; 6. SAD6: Screening period glycated haemoglobin (HbA1c) 28.0 kg/m^2; or overweight: 24.0 < BMI < 28.0 kg/m^2, and exhibiting at least one of the following manifestations: prediabetes (see 14.4 for details), hypertension, dyslipidaemia, fatty liver, weight-bearing joint pain, obesity-induced dyspnoea or obstructive sleep apnoea syndrome; 10. MAD4: During screening, weight change must be less than 5% when relying solely on dietary and exercise control for at least 12 weeks. 11. MAD5: Female subjects with potential fertility or male subjects must agree to use effective contraception from the date of signing the informed consent form until six months after the last dose of investigational medicinal product, to avoid pregnancy or causing pregnancy in their partner, and must have no plans for sperm donation, egg donation, or pregnancy. 12. MAD6: Screening criteria: Glycated haemoglobin (HbA1c) < 6.5%.
Exclusion criteria
Exclusion criteria: 1. SAD1: Diagnosed with type 1, type 2, or other types of diabetes prior to screening; 2. SAD2: Screening for individuals with a personal or family history of medullary thyroid carcinoma (MTC), C-cell hyperplasia of the thyroid, or multiple endocrine neoplasia type 2 (MEN2); or those with hereditary conditions predisposing to medullary thyroid carcinoma; 3. SAD3: Individuals with acute or chronic pancreatitis, suspected pancreatitis, or prior pancreatectomy at the time of screening; 4. SAD4: Screening for any malignant tumour within the preceding five years (excluding basal cell carcinoma that has undergone curative treatment and is considered cured); 5. SAD5: At the time of screening, subjects present with any of the following clinically significant conditions (including but not limited to gastrointestinal, renal, hepatic, neurological, haematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, or cardiovascular diseases); 6. SAD6: Screening for diseases or conditions affecting gastric emptying or gastrointestinal nutrient absorption; 7. SAD7: Exclude individuals who have undergone major surgery within the preceding three months, or who plan to undergo surgery during the study period; 8. SAD8: Individuals with a history of allergy to the investigational medicinal product or any of its constituents, or those with an allergic constitution (allergic to two or more drugs and foods); 9. SAD9: Medications used within the preceding three months that the investigator deems to have significantly impacted body weight or blood glucose levels (including prescription drugs, over-the-counter medications, Chinese herbal medicines, health supplements, etc.); 10. SAD10: Individuals who have undergone weight-loss surgery prior to screening; 11. SAD11: History of skin conditions prone to recurrence (e.g., urticaria), or presence of skin lesions at the administration site; 12. SAD12: Screening exclusion criteria: having received systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled formulations) for chronic conditions (lasting over two weeks) within the preceding three months, or having received systemic glucocorticoid therapy within the preceding month; 13. SAD13: Screening criteria: haemoglobin <110 g/L for female subjects, <120 g/L for male subjects, or any other known condition interfering with HbA1c testing; 14. SAD14: Screen for individuals who have exhibited suicidal behaviour or thoughts within the preceding six months; 15. SAD15: Individuals who have used GLP-1 receptor agonists, GLP-1R/GIPR agonists, GLP-1R/GCGR agonists, or GLP-1R/GIPR/GCGR agonists within the preceding six months prior to screening; 16. SAD16: Exclude individuals who frequently consumed alcohol within the preceding three months, defined as weekly intake exceeding 14 units of alcohol (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine); or those with clinically significant abnormal blood alcohol levels during screening; or those unable to comply with the protocol's prohibition on alcohol consumption; 17. SAD17: Exclude individuals with a history of drug use within the preceding two years, those who have used illicit drugs, or those with a positive urine drug screen prior to administration; 18. SAD18: Individuals who smoked more than five cigarettes daily in the three months prior to screening, or who were unable to abstain from smoking during the intensive pharmacokinetic sampling p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A SAD trial: body weight, waist circumference, waist-to-hip ratio;Part A SAD trial: fasting glucose, fasting insulin, fasting C-peptide, fasting glucagon, adiponectin, HOMA-IR;Part A SAD trial: fasting blood lipids (including TC, LDL-C, TG, HDL-C);Part A SAD trial: seated systolic blood pressure, diastolic blood pressure;Part A SAD trial: serum uric acid;Part A SAD trial: plasma drug concentration;Part A SAD trial: main PK parameters (including but not limited to Cmax, Tmax, Tlast and AUC0-t; if data permit, AUC0-168h, AUC0-8, AUC_%Extrap, ?z, t1/2, CL/F, Vz/F, etc.);Part B MAD trial: body weight;Part B MAD trial: plasma drug concentration;Part B MAD trial: main PK parameters after first dosing (including but not limited to Cmax, Tmax, Ctrough and AUC0-t; if data permit, AUC0-168h, AUC0-8, AUC_%Extrap, ?z, t1/2, CL/F and Vz/F, etc.);Part B MAD trial: main PK parameters after last dosing (including but not limited to Cmax, Tmax, Ctrough, Rac_Cmax, Rac_Ctrough, Tlast and AUC0-t; if data permit, AUC0-tau, namely AUC0-168h, AUC0-8, AUC_%Extrap, ?z, t1/2, CL/F, Vz/F and Rac_AUC, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A SAD trial: pharmacodynamic indicators (including body weight, waist circumference, waist-to-hip ratio; fasting glucose, fasting insulin, fasting C-peptide, fasting glucagon, fasting blood lipids [TC, LDL-C, TG, HDL-C], adiponectin, HOMA-IR; seated systolic blood pressure, diastolic blood pressure; serum uric acid);Part B MAD trial: body weight;Part B MAD trial: waist circumference, waist-to-hip ratio;Part B MAD trial: fasting glucose, fasting insulin, fasting C-peptide, fasting glucagon, adiponectin, HOMA-IR;Part B MAD trial: fasting blood lipids (including TC, LDL-C, TG, HDL-C);Part B MAD trial: seated systolic blood pressure, diastolic blood pressure;Part B MAD trial: pharmacodynamic indicators (including body weight, waist circumference, waist-to-hip ratio; fasting glucose, fasting insulin, fasting C-peptide, fasting glucagon, fasting blood lipids [including TC, LDL-C, TG, HDL-C], adiponectin, HOMA-IR; seated systolic blood pressure, diastolic blood pressure; serum uric acid; glycated hemoglobin; MRI-PDFF [only applicable to subjects with fatty liver indicated by Fibroscan/Fibrotouch results]); | — |
Countries
China
Contacts
Public ContactHu Wei
The Second Hospital of Anhui Medical University
Outcome results
None listed