RecruitingPhase 3NCT06839664

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

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

610 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity Overweight

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

Male or female 18 to 65 years of age at the time of consent(cutoff value included).
\. 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.
\. Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening.

Exclusion Criteria1

\. 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

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