Last updated: February 18, 2025
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Obesity
Diabetes Prevention
Hypertriglyceridemia
Treatment
HS-20094 injection
Placebo injection
Clinical Study ID
NCT06839664
HS-20094-301
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 1.Male or female 18 to 65 years of age at the time of consent(cutoff valueincluded).
Body mass Index(BMI)≥28 kilograms per square meter(kg/m2),or ≥24 kg/m2 andprevious 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 weeksbefore screening.
Exclusion
Exclusion Criteria:
- Diabetes mellitus 2. Weight change >5.0% after diet and exercise control for atleast 12 weeks before screening 3. Have used or are currently using weight lossdrugs within 3 months before screening 4. History of pancreatitis 5. Family orpersonal history of medullary thyroid carcinoma(MTC)or multiple endocrineneoplasia 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 asuicide attempt 8. Have a history of significant atopy (severe allergicmanifestations), multiple or severe drug allergies, or severe posttreatmenthypersensitivity reactions 9. Have a history of any malignancy within the past 5 years
Study Design
Total Participants: 610
Treatment Group(s): 2
Primary Treatment: HS-20094 injection
Phase: 3
Study Start date:
November 11, 2024
Estimated Completion Date:
February 27, 2026
Study Description
Connect with a study center
Peking University People's Hospital
Beijing, Beijing
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.