RECRUITINGPhase 3INTERVENTIONAL
A Study of HS-20094 in Chinese Adults with Overweight or Obesity
A Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of HS-20094 in Overweight and Obese Subjects
About This Trial
The main purpose of this study is to assess the Efficacy and safety of HS-20094 in overweight and obese patients. The study will last up to approximately 52 weeks.
Who May Be Eligible (Plain English)
Who May Qualify:
- 1.Male or female 18 to 65 years of age at the time of consent(cutoff value included).
2\. Body mass Index(BMI)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 and previous diagnosis with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, non-alcoholic fatty liver disease, obstructive sleep apnea.
3\. Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening.
Who Should NOT Join This Trial:
- 1\. Diabetes mellitus 2. Weight change \>5.0% after diet and exercise control for at least 12 weeks before screening 3. Have used or are currently using weight loss drugs within 3 months before screening 4. History of pancreatitis 5. Family or personal history of medullary thyroid carcinoma(MTC)or multiple endocrine neoplasia syndrome type 2(MEN-2) 6. History of moderate to severe depression, or have a history of serious mental illness 7. Any lifetime history of a suicide attempt 8. Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions 9. Have a history of any malignancy within the past 5 years
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 1.Male or female 18 to 65 years of age at the time of consent(cutoff value included).
2\. Body mass Index(BMI)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 and previous diagnosis with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, non-alcoholic fatty liver disease, obstructive sleep apnea.
3\. Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening.
Exclusion Criteria:
* 1\. Diabetes mellitus 2. Weight change \>5.0% after diet and exercise control for at least 12 weeks before screening 3. Have used or are currently using weight loss drugs within 3 months before screening 4. History of pancreatitis 5. Family or personal history of medullary thyroid carcinoma(MTC)or multiple endocrine neoplasia syndrome type 2(MEN-2) 6. History of moderate to severe depression, or have a history of serious mental illness 7. Any lifetime history of a suicide attempt 8. Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions 9. Have a history of any malignancy within the past 5 years
Treatments Being Tested
DRUG
HS-20094 injection
Administered SC
DRUG
Placebo injection
Administered SC
Locations (1)
Peking University People's Hospital
Beijing, Beijing Municipality, China