Overweight/Obesity
Conditions
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase 1b clinical study. All trial participants are required to use TQF3250 capsules or placebo. The aim is to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of multiple administrations of TQF3250 capsules. A total of 80 trial participants are required.
Interventions
DRUGTQF3250 capsules
An oral glucagon-like peptide-1 receptor agonist
DRUGTQF3250 placebo
Placebo contains no active substance.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Key inclusion criteria: 1. During screening, trial participants must be aged 18 to 65 (inclusive), and can be male or female; 2. During screening, obese individuals with a BMI of 28 to less than 40 kg/m2, or overweight individuals with a BMI of 24 to less than 28 kg/m2 accompanied by at least one of the weight-related comorbidities. 3. According to the self-reported information of the trial participants, they had undergone at least 3 months of simple lifestyle intervention before screening, and their weight change in the past 3 months was less than 5%. 4. Women of childbearing age should agree to take effective contraceptive measures during the study period and for 6 months after its completion (note: oral hormonal contraceptives should not be relied upon solely for contraception), and they must have a negative blood pregnancy test within 7 days prior to study enrollment; men should agree to take effective contraceptive measures during the study period and for 6 months after its completion. 5. Volunteer to sign the informed consent form and are willing to strictly adhere to the requirements and restrictions outlined in the informed consent form and this protocol throughout the entire research period, including but not limited to: managing diet and exercise lifestyle, taking the study medication as scheduled, keeping a research diary, and completing relevant questionnaires.
Exclusion criteria
* Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event | Baseline up to 14 weeks | Incidence and Severity of All Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs) |
| Abnormal clinical examination findings | Baseline up to 14 weeks | Incidence of abnormal clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram,etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve from 0 to 24 hours(AUC0-24h) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | AUC0-24h following the first administration at target dose, and AUC0-24h after multiple administrations |
| Area Under the Curve from time zero to infinity(AUC0-∞) | pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6hours post-dose Days 36,50,64,78; pre-1st dose & 1,2,4,6,8,12,24hours post target dose; pre-dose & 1,2,4,6,8,12,24hours post Days 35,42; pre-dose & 1,2,4,6,8,12,24,48,96hours post Day 84. | AUC0-∞ following the first administration at target dose, and AUC0-∞ after multiple administrations |
| Area Under the Curve from time zero to the last quantifiable time point(AUC0-t) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | AUC0-t after multiple administrations |
| Maximum Plasma Concentration(Cmax) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | Cmax following the first administration at target dose |
| Minimum Steady-State Concentration(Css-min) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | Css-min after multiple administrations |
| Maximum Steady-State Concentration(Css-max) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | Css-max after multiple administrations |
| Average Steady-State Concentration(Css-avg) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | Css-avg after multiple administrations |
| Elimination Half-Life(t1/2) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | t1/2 following the first administration at target dose and t1/2 after multiple administrations |
| Time to Maximum Concentration(Tmax) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | Tmax after multiple administrations |
| Apparent Oral Clearance (CL/F) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | CL/F following the first administration at target dose and CL/F after multiple administrations |
| Apparent Volume of Distribution during Elimination Phase(Vz/F) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | Vz/F following the first administration at target dose |
| Apparent Volume of Distribution at Steady State(Vss/F) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | Vss/F after multiple administrations |
| Terminal elimination rate constant(λz) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | λz following the first administration at target dose and λz after multiple administrations |
| Accumulation Ratio (Rac) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | Rac after multiple administrations |
| Dose Fluctuation(DF) | Pre-dose Days 1,8,15,22,29,36,50,64,78; 4-6 hours post-dose Days 36,50,64,78; pre-first dose and 1,2,4,6,8,12,24 hours post target dose; pre-dose and 1,2,4,6,8,12,24 hours post Days 35,42; pre-dose and 1,2,4,6,8,12,24,48,96 hours post Day 84. | DF after multiple administrations |
| Body Weight | Baseline up to 12 weeks | Percentage change in body weight compared to baseline, as well as the proportion of trial participants whose body weight decreased by ≥5%, ≥10%, and ≥15% compared to baseline |
| Body Mass Index (BMI) | Baseline up to 12 weeks | Change in BMI compared to baseline |
| Waist Circumference | Baseline up to 12 weeks | Change from baseline in waist circumference |
| Hip circumference | Baseline up to 12 weeks | Change from baseline in hip circumference |
| waist-to-hip ratio | Baseline up to 12 weeks | Change from baseline in waist-to-hip ratio |
| Glycated hemoglobin (HbA1c) | Baseline up to 12 weeks | Change from baseline in HbA1c |
| Fasting Plasma Glucose (FPG) | Baseline up to 12 weeks | Change from baseline in FPG |
| C-peptide | Baseline up to 12 weeks | Change in C-peptide compared to baseline |
| Insulin | Baseline up to 12 weeks | Change in Insulin compared to baseline |
| blood pressure | Baseline up to 12 weeks | Changes in systolic and diastolic blood pressure compared to baseline |
| blood lipids | Baseline up to 12 weeks | Changes in blood lipids compared to baseline |
Countries
China
Contacts
CONTACTLinong Ji, Doctor
Outcome results
None listed