Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05881837

Collaborator

(none)

240

Enrollment

Arms

10.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.

Condition or Disease	Intervention/Treatment	Phase
Overweight or Obesity	Drug: HRS9531 injection Drug: HRS9531 injection Drug: HRS9531 injection Drug: HRS9531 injection Drug: HRS9531 injection Placebo Drug: HRS9531 injection Placebo Drug: HRS9531 injection Placebo Drug: HRS9531 injection Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical studyA multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical study

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group A HRS9531 injection	Drug: HRS9531 injection HRS9531 injection: dose level 1
Experimental: Treatment group B HRS9531 injection	Drug: HRS9531 injection HRS9531 injection: dose level 2
Experimental: Treatment group C HRS9531 injection	Drug: HRS9531 injection HRS9531 injection: dose level 3
Experimental: Treatment group D HRS9531 injection	Drug: HRS9531 injection HRS9531 injection: dose level 4
Placebo Comparator: Treatment group E HRS9531 injection Placebo	Drug: HRS9531 injection Placebo Placebo arm matching active arm HRS9531 injection dose level 1
Placebo Comparator: Treatment group F HRS9531 injection Placebo	Drug: HRS9531 injection Placebo Placebo arm matching active arm HRS9531 injection dose level 2
Placebo Comparator: Treatment group G HRS9531 injection Placebo	Drug: HRS9531 injection Placebo Placebo arm matching active arm HRS9531 injection dose level 3
Placebo Comparator: Treatment group H HRS9531 injection Placebo	Drug: HRS9531 injection Placebo Placebo arm matching active arm HRS9531 injection dose level 4

Outcome Measures

Primary Outcome Measures

Percentage change in body weight [Week 0, Week 24]
Percentage Change from baseline in body weight after 24 weeks of treatment

Secondary Outcome Measures

Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment [Week 24]
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment [Week 24]
Change from baseline in body weight after 24 weeks of treatment [Week 0, Week 24]
Change from baseline in waist circumference after 24 weeks of treatment [Week 0, Week 24]
Change from baseline in BMI after 24 weeks of treatment [Week 0, Week 24]
Change from baseline in blood pressure after 24 weeks of treatment [Week 0, Week 24]
Change from baseline in total cholesterol after 24 weeks of treatment [Week 0, Week 24]
Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment [Week 0, Week 24]
Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment [Week 0, Week 24]
Number of AEs During the Trial [Week 0 to Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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;
At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
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:

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;
Uncontrollable hypertension;
PHQ-9 score ≥15;
Medical history or illness that affects your 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 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;
Use of any medication or treatment that may have caused significant weight change within 3 months;
History of bariatric surgery;
Known or suspected hypersensitivity to trial product(s) or related products;
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;
history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
Surgery is planned during the trial;
Mentally incapacitated or speech-impaired;
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fujian Shengdi Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fujian Shengdi Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05881837

Other Study ID Numbers:

HRS9531-201

First Posted:

May 31, 2023

Last Update Posted:

May 31, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Overweight

Study Results

No Results Posted as of May 31, 2023