Phase
Condition
Weight Loss
Diabetes Prevention
Obesity
Treatment
HD1916
semaglutide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years old (at the time of signing ICF), both male and female;
BMI≥28 kg/m^2 during screening;
Within 90 days before screening, the weight change range controlled by diet andexercise alone is less than 5% (see section 1.3 for the calculation formula);
Voluntarily participate in the trial and sign the informed consent.
Exclusion
Exclusion Criteria:
Meet any of the following requirements: (1) HbA1c≥6.5% or fasting venous bloodglucose ≥7.0 mmol/L during screening; (2) a history of type 1 or type 2 or aspecific type of diabetes;
Obesity is caused by drugs or diseases (e.g. Cushing's syndrome, acromegaly,etc.); or weight gain caused by increased non-fat content (e.g. edema);
Received (including) drug therapy with GLP-1 receptor agonists (single target,double target, or multiple target) within 90 days prior to screening;
Received any other drug or product or treatment within 90 days prior to screeningthat the investigator determines will affect the assessment of weight efficacy ofthe trial, including but not limited to drugs or products or treatments that containoverweight/obesity or equivalent meaning in the label indications, hypoglycemicdrugs, tricyclic antidepressants, antipsychotic or antiepileptic drugs (such assodium valproate, citalopram, etc.), systemic use of glucocorticoids, etc.;
Previous bariatric metabolic surgery (except for previous liposuction, abdominalplastic surgery, intragastric balloon extraction or duodenal jejunal cannulationextraction > 1 year), or planned to receive any surgical treatment during thetrial that might affect the evaluation of weight efficacy;
Past allergy or suspected allergy to GLP-1 receptor agonists, or past allergy toinvestigational drug ingredients;
Participated in any other trial and received at least one treatment in the 90 daysprior to screening;
Thyroid function is unstable or uncontrolled 90 days before screening, orTSH> 6.0 mIU/L or < 0.4 mIU/L at screening;
Previous or family history of medullary thyroid carcinoma or multiple endocrineadenomatosis type 2 (MEN-2) before screening;
Diagnosis of malignant tumors within 5 years prior to screening (except cured skinbasal cell carcinoma or cervical carcinoma in situ);
Have any of the following major cardiovascular and cerebrovascular history in the 180 days prior to screening: history of myocardial infarction, coronary angioplastyor bypass surgery, valvular heart disease or heart valve repair, clinicallysignificant and treatment-requiring arrhythmia, unstable angina pectoris,decompensated cardiac insufficiency (NYHA Class III or IV), transient ischemicattack, cerebrovascular accident, etc.;
Serious gastrointestinal disease (e.g. abnormal gastric emptying, inflammatory boweldisease) before or during screening;
Patients with moderate to severe depression at the time of screening, or the totalscore of PHQ-9 at the time of screening ≥15 points; or history of other seriousmental illness (e.g., schizophrenia, bipolar disorder); or have a history ofsuicidal thoughts, attempted suicide or suicidal behavior;
The presence of any of the following before or during screening: chronicpancreatitis, acute pancreatitis, symptomatic gallbladder disease (exceptcholecystectomy);
Any of the following items should be met during screening: (1) systolic bloodpressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; (2) QTcF interval of ECG >450 ms for male or >470 ms for female; (3) eGFR< 30mL/min/1.73 m^2, eGFR is calculated according to CKD-EPI formula; (4) ALT or AST > 3× upper limit of normal value; (5) blood amylase or blood lipase > 1.5× the upper limit of normal value; (6) blood triglyceride > 5.7 mmol/L; (7) calcitonin ≥50ng/L (pg/mL); (8) HIV antibody or HCV antibody or HBsAg positive (except for HBsAg positive but HBV DNA quantitative test results are not higher thanthe upper limit of the test reference range and no anti-HBV drugs are used duringscreening);
A history of drug abuse, drug use or alcohol dependence;
Total blood donation ≥400 mL or one-time blood loss ≥400 mL within 90 days beforescreening;
Fertile female subjects are pregnant or lactating at the time of screening, or hadpositive HCG blood; or fertile male or female subjects and their partners are unableto use effective contraception during the trial period and within 3 months after theend of treatment;
Other situations in which the investigator does not consider participation in thestudy appropriate.
Study Design
Connect with a study center
Peking University People's Hospital
Beijing, Beijing Municipality 100044
ChinaSite Not Available

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