A Study of HS-20094 in Chinese Adults With Overweight or Obesity

NCT06839664 | Completed Phase 3

• 1 other identifier: HS-20094-301
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Percent Change from Baseline in Body Weight

  Percent Change from Baseline in Body Weight

  Baseline, week 48

• Percentage of Participants Who Achieve weight loss≥ 5% from Baseline

  Percentage of Participants Who Achieve weight loss≥ 5% from Baseline

  Baseline, week 48

Secondary Outcomes (3)

• Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline

  Baseline, week 4

• Change in waist circumference from baseline at week 48

  Baseline, week 48

• Percentage change in body weight from baseline at week 24

  Baseline, week 24

Study Arms (4)

HS-20094 5mg

EXPERIMENTAL

Drug: HS-20094 injection

HS-20094 10mg

EXPERIMENTAL

Drug: HS-20094 injection

HS-20094 15mg

EXPERIMENTAL

Drug: HS-20094 injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo injection

Interventions

HS-20094 injection DRUG

Administered SC

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

Placebo injection DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diabetes mellitus
• Weight change \>5.0% after diet and exercise control for at least 12 weeks before screening
• Have used or are currently using weight loss drugs within 3 months before screening
• History of pancreatitis
• Family or personal history of medullary thyroid carcinoma(MTC)or multiple endocrine neoplasia syndrome type 2(MEN-2)
• History of moderate to severe depression, or have a history of serious mental illness
• Any lifetime history of a suicide attempt
• Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
• Have a history of any malignancy within the past 5 years

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: November 16, 2024
• Primary Completion: January 4, 2026
• Study Completion: January 30, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

CN (1)