A Study of HS-20094 Evaluating Weight Loss in Obese and Overweight Chinese Subjects

NCT06118021 | Unknown Phase 2

• 1 other identifier: HS-20094-202
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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 and 12-20 weeks maintain treatment and 6 weeks follow up.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Body Weight

  Percent Change from Baseline in Body Weight

  From Week 0 to Week 24

Secondary Outcomes (9)

• Number of AEs During the Trial

  From Week 0 to Week 24

• Change from Baseline in Patient Health Questionnaire-9 (PHQ-9)

  From Week 0 to Week 24

• Change from Baseline in Columbia Suicide Severity Rating scale ( C-SSRS)

  From Week 0 to Week 24

• 12-lead electrocardiogram (ECG) parameters: PR, R-R, QRS and QTcF (average)

  From Week 0 to Week 24

• Change from baseline in waist circumference after 24 weeks of treatment

  From Week 0 to Week 24

Study Arms (4)

HS-20094 5mg

EXPERIMENTAL

Drug: HS-20094 administered subcutaneously (SC) once a week. Drug: Placebo administered subcutaneously (SC) once a week.

Drug: HS-20094; Drug: Placebo

HS-20094 10mg

EXPERIMENTAL

Drug: HS-20094 administered subcutaneously (SC) once a week. Drug: Placebo administered subcutaneously (SC) once a week.

Drug: HS-20094; Drug: Placebo

HS-20094 15mg

EXPERIMENTAL

Drug: HS-20094 administered subcutaneously (SC) once a week. Drug: Placebo administered subcutaneously (SC) once a week.

Drug: HS-20094; Drug: Placebo

HS-20094 20mg

EXPERIMENTAL

Drug: HS-20094 administered subcutaneously (SC) once a week. Drug: Placebo administered subcutaneously (SC) once a week.

Drug: HS-20094; Drug: Placebo

Interventions

HS-20094 DRUG

Administered SC

Also known as: HS-20094 injection

HS-20094 10mg; HS-20094 15mg; HS-20094 20mg; HS-20094 5mg

Placebo DRUG

Administered SC

Also known as: Placebo injection

HS-20094 10mg; HS-20094 15mg; HS-20094 20mg; HS-20094 5mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. History of bariatric surgery. 7. History of diabetes. 8. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening.
• \. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
• \. 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.
• \. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness.
• \. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening.
• \. 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.
• \. 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.
• \. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme,and their immediate family members.
• \. 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (2)

the Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 100044, China

RECRUITING

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 7, 2023
• Study Start: October 16, 2023
• Primary Completion: August 30, 2024
• Study Completion: October 16, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-10

Locations

CN (2)