Clinical trial NCT05881837: Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight or Obesity
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical study
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. Male or female subjects, 18-65 years of age at the time of signing informed consent;
3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
4. 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:

1. 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;
2. Uncontrollable hypertension;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects your weight;
5. History of diabetes;
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. 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;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;
11. Use of any medication or treatment that may have caused significant weight change within 3 months;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. 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;
15. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
16. Surgery is planned during the trial;
17. Mentally incapacitated or speech-impaired;
18. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
19. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Primary outcomes:
measure: Percentage change in body weight
timeFrame: Week 0, Week 24
Secondary outcomes:
measure: Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment
timeFrame: Week 24
measure: Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment
timeFrame: Week 24
measure: Change from baseline in body weight after 24 weeks of treatment
timeFrame: Week 0, Week 24
measure: Change from baseline in waist circumference after 24 weeks of treatment
timeFrame: Week 0, Week 24
measure: Change from baseline in BMI after 24 weeks of treatment
timeFrame: Week 0, Week 24
measure: Change from baseline in blood pressure after 24 weeks of treatment
timeFrame: Week 0, Week 24
measure: Change from baseline in total cholesterol after 24 weeks of treatment
timeFrame: Week 0, Week 24
measure: Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment
timeFrame: Week 0, Week 24
measure: Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment
timeFrame: Week 0, Week 24
measure: Number of AEs During the Trial
timeFrame: Week 0 to Week 56
measure: Percentage change in body weight
timeFrame: Week 0, Week 32
measure: Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment
timeFrame: Week 32
measure: Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment
timeFrame: Week 32
measure: Change from baseline in body weight after 32 weeks of treatment
timeFrame: Week 0, Week 32
measure: Change from baseline in waist circumference after 32 weeks of treatment
timeFrame: Week 0, Week 32
measure: Change from baseline in BMI after 32 weeks of treatment
timeFrame: Week 0, Week 32
measure: Change from baseline in blood pressure after 32 weeks of treatment
timeFrame: Week 0, Week 32
measure: Change from baseline in total cholesterol after 32 weeks of treatment
timeFrame: Week 0, Week 32
measure: Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment
timeFrame: Week 0, Week 32
measure: Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment
timeFrame: Week 0, Week 32
Other outcomes:
Locations:
city: Hefei
country: China
facility: The second affiliated hospital of Anhui medical university
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Huadu District People's Hospital of Guangzhou
state: Guangdong
city: Shenzhen
country: China
facility: The people's hospital of Longhua.Shenzhen
state: Guangdong
city: Nanning
country: China
facility: Department of Endocrinology，Sencond Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
state: Henan
city: Nanyang
country: China
facility: The First Affiliated Hospital of Nanyang Medical College
state: Henan
city: Huangshi
country: China
facility: The Central Hospital Of Huangshi
state: Hubei
city: Wuhan
country: China
facility: The Third People's Hospital of Hubei Province
state: Hubei
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Lianyungang
country: China
facility: Lianyungang Hospital of TCM
state: Jiangsu
city: Lianyungang
country: China
facility: The First People's Hospital Of Lianyungang
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: North Jiangsu People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
city: Taiyuan
country: China
facility: Second hospttoal of Shanxi medical University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Medical College
state: Xian
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
state: Zhejiang
Study officials:
References: