Overweight and Obesity
Conditions
Keywords
GLP-1R
Brief summary
This randomized, double-blind, placebo-controlled Phase I clinical study was designed to evaluate the tolerability and safety, PK profile, immunogenicity of CPX101 in a single dose in healthy participants and multiple doses in overweight and obese patients, and to initially explore the efficacy of multiple doses in weight loss. The study was divided into two parts: single administration and dose escalation (SAD) and multiple administration and dose escalation (MAD).
Detailed description
SAD: Three dose levels (80mg, 120mg, 160mg and200mg) were preset for this phase, and a total of 32 healthy participants were planned to be included. According to the dose increment principle, starting from the dose of 80mg, increasing successively to the high dose, and proceeding in sequence. MAD: The study was planned to include 48 adult overweight or obese participants, with a preset group of four cohorts, each with 12 participants. MAD1 to MAD 3cohorts were dosed with titration starting at 40mg and given once 1 week (QW) in each cohort. Up to the target dose of 80mgQ2W, 120mg Q2W and 160mg Q2W whereas MAD4 cohort were dosed with titration starting at 80mg and gived once 2week (Q2W) and up to target dose of 240 mg and exploratory of 320mg
Interventions
BIOLOGICALCPX101 or placebo 80mg single dose
Subcutaneous injection of CPX101 or placebo
BIOLOGICALCPX101 or placebo 120mg single dose
Subcutaneous injection of CPX101 or placebo
BIOLOGICALCPX101 or placebo 160mg single dose
Subcutaneous injection of CPX101 or placebo
BIOLOGICALCPX101 or placebo 80mg Q2W
Subcutaneous injection of CPX101 or placebo
BIOLOGICALCPX101 or placebo 120mg Q2W
Subcutaneous injection of CPX101 or placebo
BIOLOGICALCPX101 or placebo 160mg Q2W
Subcutaneous injection of CPX101 or placebo
BIOLOGICALCPX101 or placebo 320mg Q2W
Subcutaneous injection of CPX101 or placebo
Sponsors
Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
SAD inclusion criteria: 1. Healthy male or female participants aged 18 to 65 (inclusive) at the time of signing the informed consent form; 2. When screening, body mass index (BMI)\>20 and\<28 kg/m2; 3. During the entire study period, participants must agree to maintain stable dietary and physical activity habits, and have no plans to change their dietary or exercise habits or lose weight; 4. Participants are able to understand and voluntarily sign a written Informed Consent Form (ICF), and are able to complete the relevant procedures and checks in accordance with the protocol; 5. Female participants must meet the following conditions: 1. No possibility of reproduction; 2. Possible fertility: The serum pregnancy test result was negative during screening, and effective contraceptive measures were agreed to be taken throughout the entire trial period and within 12 weeks after the last dose. Egg donation is not allowed within 12 weeks after the last dose; 6. Male participants whose female partners have the potential to conceive must take effective contraceptive measures throughout the entire trial period and within 12 weeks after the last dose, and are not allowed to donate sperm. MAD inclusion criteria: 1. Male or female participants aged 18 to 75 (inclusive) at the time of signing the informed consent form; 2. When screening, obese individuals with 28 ≤ BMI\<40kg/m2, or overweight individuals with 24 ≤ BMI\<28kg/m2 and at least one of the following weight related comorbidities; 3. During the first 3 months of screening, the weight remained stable; 4. Willing to maintain a stable diet and exercise habits according to the research protocol throughout the entire study period; 5. Participants are able to understand and voluntarily sign a written informed consent form (ICF), and are able to complete the relevant procedures and checks in accordance with the protocol; 6. Female participants must meet the following conditions: 1. No possibility of reproduction; 2. Possible fertility: The serum pregnancy test result was negative during screening, and effective contraceptive measures were agreed to be taken throughout the entire trial period and within 12 weeks after the last dose. Egg donation is not allowed within 12 weeks after the last dose; 7. Male participants whose female partners have the potential to conceive must take effective contraceptive measures throughout the entire trial period and within 12 weeks after the last dose, and are not allowed to donate sperm.
Exclusion criteria
SAD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety of CPX101 | Up to 84 days after administration | All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in healthy participants |
| The tolerability of CPX101 | Up to 84 days after administration | All AE/SAEs and other findings from vital signs(temperature, pulse, respiration, blood pressure）, physical examination(general conditions, skin, head and neck, chest, abdomen, back, four limbs, nervous system), lab tests(such as FSH, hematology, urinalysis, liver and kidney functions, electrolytes, fasting plasma glucose, blood lipids, blood amylase and lipase, calcitonin, thyroid function et al) and ECG(heart rate and measures PR, QRS, QT, and QTc intervals) will be collected from the start of screening visit to the end of the study in healthy participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) characteristics of CPX101 | Up to 84 days after administration | Measurement of the concentration of CPX101 in serum after single dose injection in healthy participants |
| Preliminary efficacy of CPX101 | At week 16 after administration | Evaluate the preliminary efficacy parameters (including body weight loss, waist circumference, BMI et al.) of multiple administration of CPX101 in overweight and obese patients. 1) body weight record the value in kilograms. 2) waist and hip circumference record the value in cm, Waist-to-hip ratio = waist circumference/hip circumference. 3) BMI = weight (kg) / (height \[m\])\^2. |
| Immunogenicity of CPX101 | Up to 196 days after administration | Measurement of the anti-CPX101 antibody in serum after multiple administrations in overweight and obese patients |
Countries
China
Outcome results
None listed