Overweight, Obesity
Conditions
Interventions
SAD Phase D005 Drug Group:Seven dose groups (0.01 mg, 0.05 mg, 0.15 mg, 0.5 mg, 1.5 mg, 3 mg, and 5 mg) were administered by a single subcutaneous injection on an empty stomach at the site of the abdo
SAD stage D005 placebo group:Seven dose groups (0.01 mg, 0.05 mg, 0.15 mg, 0.5 mg, 1.5 mg, 3 mg, and 5 mg) were administered by a single subcutaneous injection on an empty stomach at the site of the a
MAD Phase D005 Drug Group:Four dose groups (target doses of 0.5 mg, 1.5 mg, X mg, and Y mg) were titrated to the target dose by starting dose titration once (titrated starting doses of 0.15 mg, 0.5 mg
MAD stage D005 placebo group:The 4 dose groups were titrated and administered once to the target dose via the starting dose, and the target dose was administered continuously for 4 weeks, subcutaneous
Sponsors
Beijing Gobroad Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form, be able to communicate well with the investigator, and understand and comply with the requirements and limitations of this study; 2. Part 1: Age 18 - 45 years (including borderline value, based on the day of signing the informed consent), male or female; Part 2: Age 18 - 60 years (including 18 years, excluding 60 years, based on the day of signing the informed consent), male or female; 3. Part 1: weight > 50 kg at screening and body mass index (BMI) in the range of 19.0 - 28.0 kg/m2 (excluding borderline values) (BMI = weight [kg]/height [m]^2); Part 2: weight > 50 kg at screening and BMI in the range of 19.0 - 28.0 kg/m2 (excluding borderline values); Part 2: body weight > 50 kg at screening and BMI in the range of 19.0 - 28.0 kg/m2 (excluding borderline values). - 28.0 kg/m2 range (excluding borderline values, for Cohort 1 and Cohort 2), or BMI >= 28.0 kg/m^2 (for Cohort 3 and Cohort 4) (BMI = weight [kg]/height [m]^2); 4. Participants had a stable exercise and lifestyle during the 3 months prior to screening and were of relatively stable weight (asked); 5. Part 1: HbA1c < 6% at screening; Part 2: HbA1c < 6% (Cohort 1 and Cohort 2), or HbA1c < 6.5% (Cohort 3 and Cohort 4) at screening; 6. Participants of childbearing potential have no plans for childbearing, egg or sperm donation from the time of signing the informed consent form until 3 months after the last dose of study medication and must comply with contraceptive regulations during this period (see Appendix 1) and must agree to use at least one highly effective non-hormonal method of contraception; or the participant himself/herself or his/her partner has been sterilized at least 6 months prior to the Screening Visit.
Exclusion criteria
Exclusion criteria: 1. allergy or contraindication to the use of the active ingredient of the study drug or its excipients; 2. a history of significant multiple and/or severe allergies, including food allergies (Note: Persons suffering from seasonal allergies may be allowed to participate, except for those with persistent symptoms); 3. have a history of depression or post-traumatic stress disorder within 2 years prior to the screening visit; or have engaged in suicidal behavior or suicidal ideation; or have suicidal ideation as judged by the investigator (psychiatrists may be called in for evaluation if needed), which may increase the risk of participation in the study, and in the judgement of the investigator, participation in the study is inappropriate ; 4. a history of other serious metabolic, infectious, cardiovascular, gastrointestinal, hepatic, renal/urinary, respiratory, endocrine, hematological, immune, neurological, reproductive, cutaneous, malignant neoplasm or malignant neoplasm in clinical remission (with the exception of resected basal cell carcinoma of the skin and cervical cancer in situ with no evidence of recurrence), or psychiatric disorders requiring medication and/or other treatment, including dietary restrictions and physical therapy. In the opinion of the investigator, participation in this study is not appropriate; 5. have undergone major surgical procedures (e.g., gastrointestinal surgery, oncologic surgery, etc., excluding appendectomy) within 6 months prior to screening that, in the investigator's assessment, may affect the participant's ability to participate in the trial or pose a risk to the participant ; 6. be diagnosed with gastroparesis or have an abnormality of gastric emptying that is considered clinically significant by the investigator; 7. participants with a history of dyspepsia, chronic nausea, or chronic diarrhea (3 3 loose stools per day for 3 4 weeks) within 6 months prior to screening, or who have experienced severe gastrointestinal disease (e.g., active ulcers, pyloric obstruction, inflammatory bowel disease, etc.), or who have been on long-term use of medications directly affecting gastrointestinal motility for chronic gastrointestinal disease, who have been assessed as unsuitable by the investigator for participation in this study; 8. a known history of type 1 or type 2 diabetes mellitus, or other endocrine disease that may affect glucose metabolism, or a previous history of hypoglycemic episodes; 9. acute or chronic heart failure, acute myocardial infarction, unstable angina, transient ischemic attack (TIA), or cerebrovascular accident within 6 months prior to Screening; 10. 12-lead ECG abnormalities (e.g., QTcF >= 450 ms, PR interval 220 ms, second- or third-degree atrioventricular block, ventricular conduction delay [i.e., QRS > 120 ms], right bundle-branch block, left bundle-branch block, and pre-excitation syndrome) at the screening period or at baseline that, in the judgment of the investigator, are of clinical significance; or any other conditions that may have an impact on ECG QT interval analysis; or any medication that, in the judgment of the investigator, is being taken or has been taken within 1 month prior to screening that may affect the QT interval, e.g., cisapride, macrolide antibiotics, and psychotropic medications (phenothiazines [chlorpromazine, phenazine, fenetylline, fluphenazine, thioridazine], and butyrylbenzenes [haloperidol, haloperidol]); 11. a prior dia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AE);Other safety data, including but not limited to: reasons for study withdrawal, laboratory tests, vital signs, electrocardiogram (ECG), physical findings; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK Parameters of CMS-D005;Weight loss variables and their change from baseline after drug administration: body weight, waist circumference; | — |
Countries
China
Contacts
Public ContactFang Hou, Xiaohui Guo
Beijing Gobroad Hospital
Outcome results
None listed