Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects

NCT06054698 | Unknown Phase 2

• 1 other identifier: HRS9531-203
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 weeks of treatment.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• Percentage change in body weight

  Week 0, Week 36

Secondary Outcomes (11)

• Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 36 weeks of treatment

  Week 36

• Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 36 weeks of treatment

  Week 36

• Proportion of Subjects with weight loss of ≥15% from baseline in body weight after 36 weeks of treatment

  Week 36

• Change from baseline in body weight after 36 weeks of treatment

  Week 0, Week 36

• Change from baseline in waist circumference after 36 weeks of treatment

  Week 0, Week 36

Study Arms (2)

HRS9531 injection

EXPERIMENTAL

Drug: HRS9531 injection

HRS9531 injection Placebo

PLACEBO COMPARATOR

Drug: HRS9531 injection Placebo

Interventions

HRS9531 injection DRUG

HRS9531 injection , QW，36 weeks

HRS9531 injection

HRS9531 injection Placebo DRUG

HRS9531 injection Placebo，QW，36 weeks

HRS9531 injection 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:

• Able and willing to provide a written informed consent.
• Male or female subjects, 18-65 years of age at the time of signing informed consent.
• ≤BMI≤ 40.0 kg/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.
• PHQ-9 score ≥15.
• Medical history of illness that affects weight.
• History of diabetes.
• Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening.
• History of acute cardiovascular and cerebrovascular diseases.
• Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ.
• Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness.
• History of alcohol , medication or drug abuse within 1 year prior to screening.
• Use of any medication or treatment that may cause significant weight change within 3 months.
• History of bariatric surgery.
• Subjects participating in QT/QTc studies need to comply with relevant examinations.
• Known or suspected hypersensitivity to trial product(s) or related products.
• Participation in other clinical trials within 3 month prior to screening.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

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

Central Study Contacts

Hongcheng Hu

CONTACT

13672085298; hongcheng.hu@hengrui.com

Junmeng Shi

CONTACT

17721288226; Junmeng.shi.js12@hengrui.com

Study Design

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

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: October 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09