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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06532578




Registration number
NCT06532578
Ethics application status
Date submitted
18/07/2024
Date registered
1/08/2024
Date last updated
28/08/2024

Titles & IDs
Public title
Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Trial to Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus
Secondary ID [1] 0 0
CPX101-?-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CPX101 or placebo 120mg Q2W
Treatment: Other - CPX101 or placebo 160mg Q4W
Treatment: Other - CPX101 or placebo 160mg Q2W
Treatment: Other - CPX101 or placebo 240mg Q4W
Treatment: Other - CPX101 or placebo 240mg Q2W

Experimental: Cohort 1 -

Experimental: Cohort 2 -

Experimental: Cohort 3 -

Experimental: Cohort 4 -

Experimental: Cohort 5 -


Treatment: Other: CPX101 or placebo 120mg Q2W
Subcutaneous injection of CPX101 or placebo

Treatment: Other: CPX101 or placebo 160mg Q4W
Subcutaneous injection of CPX101 or placebo

Treatment: Other: CPX101 or placebo 160mg Q2W
Subcutaneous injection of CPX101 or placebo

Treatment: Other: CPX101 or placebo 240mg Q4W
Subcutaneous injection of CPX101 or placebo

Treatment: Other: CPX101 or placebo 240mg Q2W
Subcutaneous injection of CPX101 or placebo
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of CPX101 in body weight loss in Kg
Timepoint [1] 0 0
Up to 24 weeks after administration
Secondary outcome [1] 0 0
Other efficacy parameters of CPX101(Waist circumference in centimeters)
Timepoint [1] 0 0
Up to 24 weeks after administration
Secondary outcome [2] 0 0
Other efficacy parameters of CPX101(BMI)
Timepoint [2] 0 0
Up to 24 weeks after administration
Secondary outcome [3] 0 0
Incidence of AE/SAE
Timepoint [3] 0 0
Up to 36 weeks
Secondary outcome [4] 0 0
The plasma concentration of CPX101
Timepoint [4] 0 0
Up to 24 weeks after administration
Secondary outcome [5] 0 0
Immunogenicity of CPX101
Timepoint [5] 0 0
Up to 24 weeks after administration

Eligibility
Key inclusion criteria
Subjects who are eligible for the study must meet all of the following inclusion criteria.

1. Provide signed informed consent.
2. Males or females aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF).
3. Body mass index (BMI) = 30 kg/m2, or 27=BMI<30 kg/m2 with at least one of weight-related comorbidities.
4. Body weight is stable during the 3-month period prior to screening.
5. In the investigator's opinion, are capable and willing to follow the study procedures of the study, including but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan), maintain a study diary, and complete required questionnaires.
6. At least one self-reported unsuccessful weight loss attempt per investigator judgement.
7. Satisfy the following:

a) For female subjects: i. Female subjects with childbearing potential: Serum pregnancy test result at screening must be negative, and must agree to use at least one of the highly effective contraceptive methods (refer to Appendix 4) from the time of signing the ICF until 12 weeks after the last dose of study drug. If a female subject decides to use any one of user-dependent contraceptive method (refer to Appendix 4), then a second method of contraceptive barrier is required.

ii. Female subjects with non-childbearing potential: Postmenopausal for at least 12 months, or documented surgically sterile (e.g. hysterectomy with or without bilateral salpingectomy and bilateral oophorectomy). Females who have only had tubal ligation or other birth control operations are NOT included.

b) For male subjects: all male subjects should refrain from sperm donation from the time of signing the ICF until 12 weeks after the last dose of study drug. If engaged in sexual relations with a female of child-bearing potential, subjects must use condoms plus 1 additional highly effective (refer to appendix 4) method of contraception during intercourse from the time of signing the ICF until 12 weeks after the last dose of study drug.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects are excluded from the trial if any of the following criteria apply:

Glycaemia-related:

1. HbA1c =6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus.
2. Treatment with glucose-lowering agent(s) within 90 days before screening.
3. There are severe hypoglycemic events of unknown cause (needing help from others to recover) from 90 days before screening to randomization, or frequent hypoglycemia or hypoglycemia-related symptoms within 30 days before screening.

Obesity-related:
4. Treatment with GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists, or any other medication for the indication of obesity within 3 months before screening.
5. Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device (excluding liposuction and/or abdominoplasty, if performed > 1 year before screening).
6. Use of drugs with an impact on body weight within 3 months before screening based on investigator's opinion.
7. Presence of any clinically significant endocrine disorders, which makes the participant unsuitable for the study, as the discretion of the investigator.

Mental health:
8. Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years before screening.
9. A Patient Health Questionnaire-9 (PHQ-9) score of = 15 at screening.
10. A lifetime history of a suicidal attempt, or suicidal behavior within 30 days before screening.
11. Suicidal ideation corresponding to Category 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening.

General safety:
12. History of acute or chronic pancreatitis, history of symptomatic gallbladder disease (participants can be enrolled if gallbladder disease has been resolved by cholecystecomy), history of pancreatic injury, and other high-risk factors that may lead to pancreatitis.
13. History of clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), serious chronic gastrointestinal disorders (e.g., active ulcer within 6 months before screening), long-term use of drugs with a direct impact on gastrointestinal motility, or gastrointestinal surgery (excluding endoscopic resection of gastrointestinal polyps, and appendicectomy).
14. Personal or family history of multiple endocrine neoplasia (MEN) syndrome type 2 or medullary thyroid carcinoma (MTC).
15. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer, in situ carcinomas of the cervix, in situ prostate cancer and in situ melanoma are allowed.
16. History of major cardiovascular and cerebrovascular diseases within 6 months before screening, defined as:

1. History of myocardial infarction, coronary angioplasty or bypass graft, valvular heart disease or valve repair, clinically significant arrhythmia, unstable angina, transient ischemic attack, or cerebrovascular accident;
2. New York Heart Association (NYHA) class III or IV congestive cardiac failure;
3. Or presence of abnormal ECG manifestations (excluding stable coronary heart disease) that may affect the safety judgment of the study or require medical intervention, at the discretion of the investigator.
17. Occurrence of serious trauma, serious infection, or surgery within 30 days before screening, which makes the participant unsuitable for the study, at the discretion of the investigator.
18. Known or suspected hypersensitivity to trial product(s) or related products.
19. Known or suspected abuse of alcohol (that is, alcohol consumption >14 units/week for women and >21 units/week for men) or recreational drugs.
20. Previous participation in this trial. Participation is defined as signed informed consent.
21. Participation in another clinical trial within 90 days before screening
22. The physical examination or lab results at screening meet any of the following criteria:

1. Blood pressure: systolic blood pressure (SBP) = 160 mmHg and/or diastolic blood pressure (DBP) = 100 mmHg, or systolic blood pressure (SBP) = 85 mmHg and/or diastolic blood pressure (DBP) = 55 mmHg, or addition/change or dose adjustment of antihypertensive drugs within 4 weeks before screening;
2. Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5 × the upper limit of normal (ULN); or total bilirubin > 1.5 × ULN; or alkaline phosphatase (ALP) > 1.5 × ULN;
3. Pancreatic function: amylase and/or lipase > 1.5 × ULN;
4. Renal function: renal impairment measured as estimated Glomerular Filtration Rate (eGFR, calculated by 2021 CKD-EPI) < 30 ml/min/1.73 m2 at screening;
5. Anemia of any cause, defined as hemoglobin < 120 g/L (male) or < 110 g/L (female) at screening;
6. Fasting triglyceride > 5.7 mmol/L, or addition/change or dose adjustment of lipid-lowering drugs within 4 weeks before screening;
7. Calcitonin = 20 ng/L;
8. Positive for any of the following: hepatitis B virus DNA (HBV DNA) =500IU/mL, hepatitis C virus RNA (HCV RNA) positive (=the lowest value that can be tested), human immunodeficiency virus (HIV) antibody, and Treponema pallidum antibody (TP-Ab).
23. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.
24. Female who is pregnant, breast-feeding or intends to become pregnant.
25. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the protocol.

The criteria will be assessed at the investigator's discretion unless otherwise stated.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Paratus Clinical Research - Chatswood
Recruitment postcode(s) [1] 0 0
- Chatswood

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is designed to evaluate the preliminary efficacy, safety, population PK profile, and immunogenicity of CPX101 in subjects with obesity or overweight with weight related comorbidities but without diabetes mellitus.
Trial website
https://clinicaltrials.gov/study/NCT06532578
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yunbo ZHU
Address 0 0
Country 0 0
Phone 0 0
+86 18618126060
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06532578