- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06118021
A Study of HS-20094 Evaluating Weight Loss in Obese and Overweight Chinese Subjects
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HS-20094 in Overweight and Obese Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150001
- Recruiting
- The Fourth Affiliated Hospital of Harbin Medical University
-
Contact:
- Zhifeng Cheng
- Phone Number: 010-66110802
- Email: hydsyczf@126.com
-
Harbin, Heilongjiang, China, 100044
- Recruiting
- The Fourth Affiliated Hospital of Harbin Medical University
-
Contact:
- Zhifeng Cheng, PhD
- Phone Number: 010-66110802
- Email: hydsyczf@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HS-20094 5mg
Drug: HS-20094 administered subcutaneously (SC) once a week.
Drug: Placebo administered subcutaneously (SC) once a week.
|
Administered SC
Other Names:
Administered SC
Other Names:
|
Experimental: HS-20094 10mg
Drug: HS-20094 administered subcutaneously (SC) once a week.
Drug: Placebo administered subcutaneously (SC) once a week.
|
Administered SC
Other Names:
Administered SC
Other Names:
|
Experimental: HS-20094 15mg
Drug: HS-20094 administered subcutaneously (SC) once a week.
Drug: Placebo administered subcutaneously (SC) once a week.
|
Administered SC
Other Names:
Administered SC
Other Names:
|
Experimental: HS-20094 20mg
Drug: HS-20094 administered subcutaneously (SC) once a week.
Drug: Placebo administered subcutaneously (SC) once a week.
|
Administered SC
Other Names:
Administered SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change from Baseline in Body Weight
Time Frame: From Week 0 to Week 24
|
Percent Change from Baseline in Body Weight
|
From Week 0 to Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of AEs During the Trial
Time Frame: From Week 0 to Week 24
|
Safety
|
From Week 0 to Week 24
|
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9)
Time Frame: From Week 0 to Week 24
|
From Week 0 to Week 24
|
|
Change from Baseline in Columbia Suicide Severity Rating scale ( C-SSRS)
Time Frame: From Week 0 to Week 24
|
From Week 0 to Week 24
|
|
12-lead electrocardiogram (ECG) parameters: PR, R-R, QRS and QTcF (average)
Time Frame: From Week 0 to Week 24
|
From Week 0 to Week 24
|
|
Change from baseline in waist circumference after 24 weeks of treatment
Time Frame: From Week 0 to Week 24
|
From Week 0 to Week 24
|
|
Change from baseline in BMI after 24 weeks of treatment
Time Frame: From Week 0 to Week 24
|
From Week 0 to Week 24
|
|
Change from baseline in blood pressure after 24 weeks of treatment
Time Frame: From Week 0 to Week 24
|
From Week 0 to Week 24
|
|
Change from baseline in total cholesterol after 24 weeks of treatment
Time Frame: From Week 0 to Week 24
|
From Week 0 to Week 24
|
|
Change from baseline in fasting plasma glucose(FPG)after 24 weeks of treatment
Time Frame: From Week 0 to Week 24
|
From Week 0 to Week 24
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-20094-202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight and Obesity
-
University Hospital, LilleNational Research Agency, France; European Union; University of Lille Nord de... and other collaboratorsNot yet recruitingOverweight and Obesity | Overweight, Childhood | Overweight, Infant
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
Memorial Sloan Kettering Cancer CenterRecruitingObesity | Overweight | Overweight and Obesity | Obese | Overweight or ObesityUnited States
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
Universidade do Extremo Sul Catarinense - Unidade...RecruitingObesity | Overweight and Obesity | Obesity; Endocrine | Overweight, Obesity and Other HyperalimentationBrazil
-
Mexican National Institute of Public HealthUNICEFCompleted
-
Universidade do PortoFundação para a Ciência e a Tecnologia; Administração Regional de Saúde do... and other collaboratorsCompletedOverweight and ObesityPortugal
-
University of British ColumbiaTerminatedOverweight and ObesityCanada
-
National Taiwan University HospitalCompleted
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States