Status:
UNKNOWN
A Study of HS-20094 Evaluating Weight Loss in Obese and Overweight Chinese Subjects
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a study of HS-20094 in participants with overweight and obesity. The main purpose is to learn more about how HS-20094 affects body weight. The study period including 4-12 weeks dose titration ...
Detailed Description
This is a phase 2, double-blind, randomised, placebo-controlled trial to assess the efficacy of HS-20094 in Chinese subjects with overweight or obesity. We enrolled adults (aged 18-65 years, both incl...
Eligibility Criteria
Inclusion
- Male or female subjects,18-65 years of age at the time of signing informed consent.
- BMI≥28.0kg/m2 or 24≤BMI\<28.0 kg/ m2 with at least 1 weight-related comorbidity at screening visit.
- Diet and exercise control for at least 3 months before screening visit,and less than 5 kg self-reported change within the last 3 months.
Exclusion
- 1\. Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
- 2\. poor-controlled hypertension. 3. PHQ-9 score≥15. 4. Medical history or illness that affects your weight. 5. Use of any medication or treatment that may have caused significant weight change within 3 months.
- 6\. History of bariatric surgery. 7. History of diabetes. 8. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening.
- 9\. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- 10\. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix.
- 11\. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness.
- 12\. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening.
- 13\. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening.
- 14\. Known or suspected hypersensitivity to trial product(s)or related products. 15. Female who is pregnant,breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
- 16\. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme,and their immediate family members.
- 17\. In the judgment of the investigator,there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 16 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06118021
Start Date
October 16 2023
End Date
October 16 2024
Last Update
November 7 2023
Active Locations (2)
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1
the Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 100044
2
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001