Overweight and obese
Conditions
Interventions
PartA-30mg:Single subcut. inj. KN069 30mg or placebo
PartA-12mg:Single subcut. inj. KN069 12mg or placebo.
PartA-60mg:Single subcut. inj. KN069 60mg or placebo
PartA-120mg:Single subcut. inj. KN069 120mg or placebo
PartB-groupA:Multiple abd. subcut. inj. KN069 (D1 15mg, D8 30mg, D22 30mg)
PartB-groupB:Multiple abd. subcut. inj. KN069(D1 15mg,D8 30mg,D22 60mg)
PartA-90mg:Single subcut. inj. KN069 90mg or placebo
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Men between the ages of 18 and 55 at the time of the informed consent, including the cut-off; 2.BMI:24.0 kg/m^2<=BMI<35 kg/m^2; 3.HbA1c<6.5%;3.9mmol/L<=fasting blood glucose level <7.0mmol/L; 4.Understand and be willing to follow the clinical trial protocol to complete the trial and sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1. Previous history of chronic disease or current presence of clinically significant systemic disease, for example: cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, autoimmune diseases, neurological disorder or psychiatric diseases, bacterial or viral infections, etc. 2.A history of acute or chronic pancreatitis, a personal or family history of thyroid cancer or multiple endocrine syndrome type 2(MEN2) , a history of other malignancies, and a history of acute or chronic pancreatitis; 3.A history of gastrointestinal disorders (such as esophageal reflux or gallbladder disease) or any gastrointestinal diseasessurgeries that affect gastric emptying (such as gastric bypass, pyloric stenosis, except appendectomy) or gastrointestinal disorders that are aggravated by Glucagon-like peptide-1 agonists (GLP-1RA) or Dipeptidyl peptidase-4 inhibitor (DPP-4i) ; 4.Previous gallbladder stone removal or cholecystectomy; 5.Allergic reactions to KN069 excipients or drugs of similar chemical structure or class to KN069; 6.History of drug abuse/dependence or drug inhalation/injection within 1 year before screening; 7.Any major surgery or surgery affecting drug absorption, distribution, metabolism, or excretion within 3 months prior to screening, or planned surgery during the trial (a major surgery is defined as one that targets an organ in the brain, chest, abdomen, pelvis, or extremities and results in significant tissue trauma requiring long-term recovery) ; 8.Drinking more than 14 units of alcohol per week during the 3 months before screening or during the screening period (1 unit = 360 ml of beer or 45 ml of 40% alcohol or 150 ml of wine) , and not abstaining during hospitalization; The daily alcohol consumption should not be less than 2 units during the visiting period after discharge; 9.Blood donation or blood loss >=300ml within 3 months before screening, or planned to donate blood or blood components during the trial or within 1 month after the end of the trial; 10.She had been given other drugs/vaccines in clinical trials within 2 months before screening and was in other clinical trials at the time of screening; 11.Dieting or weight-loss treatment or major lifestyle changes within 2 months (for whatever reason) before the drug is given. 12.Vaccination was given within 14 days prior to screening, or plan to receive vaccination during clinical trials, including inactivated vaccine, live attenuated vaccine, recombinant protein vaccine, recombinant adenovirus vaccine, RNA vaccine, DNA vaccine, COVID-19 vaccine; 13.Use of any prescription, over-the-counter or herbal medicine (other than vitamin mineral supplements, paracetamol, topical medications and contraceptives) within 14 days prior to administration; 14.Use of GLP-1 analogs, GLP-1 receptor agonists, or any other incretin-related prescription preparations within 3 months before administration, and other drugs that the researchers believe may have affected the trial; 15.Those who met the following criteria: 1) serum Alanine transaminase (Alt) , aspartate transaminase (AST) , Alkaline phosphatase (ALP) were more than twice the upper limit of the reference range, serum total bilirubin (TBIL) was more than 1.5 times the upper limit of the reference range, 2) fasting triglyceride (TG) was more than 5.6 mmol/L, 3) physical examination, Vital Signs, electrocardiogram, laboratory examination, and imaging showed abnormal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ECG;Vital signs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;PD-High-sensitivity c-reactive protein;BMI;Waist circumference;Immunogenicity;Insulin;C-peptide;Glucagon;Free fatty acids;Leptin; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital Central South University
Outcome results
None listed