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

Hansoh Pharma

Status and phase: Enrolling; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: HS-20094 injection; Drug: Placebo injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06839664

HS-20094-301

Details and patient eligibility

About

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.

Full description

This is a phase Ⅲ, 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 inclusive) with overweight (body-mass index [BMI] ≥24 kg/m2) accompanied by at least one obesity-related comorbidity or obesity (BMI ≥28 kg/m2) in China. Eligible participants were randomly assigned to receive once-weekly subcutaneous HS-20094 or placebo for 48 weeks. The co-primary endpoints were the percent change in bodyweight from baseline and the proportion of patients achieving weight loss≥5% from baseline after 48 weeks treatment.

Enrollment: 610 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.Male or female 18 to 65 years of age at the time of consent(cutoff value included).

  2. 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.

  3. Weight change ≤5.0% after diet and exercise control for at least 12 weeks before screening.

Exclusion criteria

• 1. Diabetes mellitus 2. Weight change >5.0% after diet and exercise control for at least 12 weeks before screening 3. Have used or are currently using weight loss drugs within 3 months before screening 4. History of pancreatitis 5. Family or personal history of medullary thyroid carcinoma(MTC)or multiple endocrine neoplasia 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 a suicide attempt 8. Have a history of significant atopy (severe allergic manifestations), multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions 9. Have a history of any malignancy within the past 5 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

610 participants in 4 patient groups, including a placebo group

HS-20094 5mg

Experimental group

Treatment:

Drug: HS-20094 injection

HS-20094 10mg

Experimental group

Treatment:

Drug: HS-20094 injection

HS-20094 15mg

Experimental group

Treatment:

Drug: HS-20094 injection

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo injection