Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mell… (NCT06532578) | Clinical Trial Compass
CompletedPhase 2
Evaluate the Safety and Efficacy of CPX101 in Overweight and Obese Subjects Without Diabetes Mellitus
Australia240 participantsStarted 2024-08-13
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Provide signed informed consent.
✓. Males or females aged 18-75 years (inclusive) at the time of signing the informed consent form (ICF).
✓. Body mass index (BMI) ≥ 30 kg/m2, or 27≤BMI\<30 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): pre-diabetes, hypertension, dyslipidaemia, obstructive sleep apnoea, ischemic cardiovascular disease, or concomitant weight-bearing joint pain.
✓. Body weight is stable during the 3-month period prior to screening, and any weight change is less than 5%.
✓. In the investigator's opinion, are capable and willing to follow the study procedure 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.
✓. At least one self-reported unsuccessful weight loss attempt per investigator judgement.
✓. Satisfy the following:
Exclusion criteria
✕. HbA1c ≥6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus.
✕. Treatment with glucose-lowering agent(s) within 90 days before screening.
✕. There are severe hypoglycemic events of unknown cause (needing help from others to recover) from 90 days before screening to randomization, or frequent hypoglycemia such as 3 or more hypoglycemic events (blood glucose ≤ 2.8 mmol/L) or hypoglycemia-related symptoms within 30 days before screening.
What they're measuring
1
Efficacy of CPX101 in body weight loss in Kg
Timeframe: Up to 24 weeks after administration
Trial details
NCT IDNCT06532578
SponsorGuangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.
✕. 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.
✕. 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.
✕. Use of drugs with an impact on body weight within 3 months before screening based on investigator's opinion.
✕. Presence of any clinically significant endocrine disorders (e.g., uncontrolled hyperthyroidism, or hypothyroidism, acromegaly, Cushing syndrome, etc.), which makes the participant unsuitable for the study, as the discretion of the investigator.
✕. 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.