Weight Management in Adult Patients With Obesity or Overweight
Conditions
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects. SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.
Interventions
DRUGXTL6001
XTL6001 is a triple-target Glucagon-like peptide-1 receptor （GLP-1R） relevant agonist, intending to manage overweight/obesity and other metabolic diseases
DRUGPlacebo
This intervention contains no active ingredients
Sponsors
Shanghai Xitaili Biomedicine Technology co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for Subjects in SAD part: 1. Age ≥ 18 and \< 65 years at screening. 2. Body mass index (BMI) ≥ 18.5 kg/m² and \< 28.0 kg/m² at screening. 3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening. 4. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions. Inclusion Criteria for Subjects in MAD part: 1. Age ≥ 18 and \< 65 years at screening. 2. BMI ≥ 18.5 kg/m2且 \< 40.0kg/m². 3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening. 4. Stable body weight (fluctuation \< 5%) for at least 3 months prior to screening. 5. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events) | SAD: up to Day 8 MAD: up to Day 57 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax of XTL6001 | Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level. | The time to maximum concentration (Tmax) of XTL6001 |
| Elimination half-life (T1/2) of XTL6001 | Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level. | t1/2 - Elimination half-life |
| Area under the plasma concentration-time curve during one dosing interval (AUC) 0-tau of XTL6001 | Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level. | AUC0-tau - Area under the plasma concentration-time curve during one dosing interval |
| AUC0-t of XTL6001 | Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level. | AUC0-t - Area under the plasma concentration-time curve from time zero to the last measurable concentration |
| Body weight | MAD: up to Day57 | Body weight |
| Body mass index （BMI） | MAD: up to Day57 | Body mass index |
| Waist circumference | MAD: up to Day57 | waist circumference |
| The maximum plasma concentration (Cmax) of XTL6001 | Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level. | Cmax - Maximum plasma concentration |
| Blood lipids | MAD: up to Day57 | Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B |
| Blood glucose | MAD: up to Day57 | Blood glucose |
| Insulin | MAD: up to Day57 | Insulin |
| Uric acid | MAD: up to Day57 | Uric acid |
| Anti-drug antibodies (ADA) | MAD: up to Day57 | Incidence of anti-drug antibodies (ADA) |
| ADA | MAD: up to D57 | Time to ADA positivity |
| Waist-to-hip ratio | MAD: up to Day57 | waist-to-hip ratio |
Countries
China
Contacts
Primary ContactXiao Hua Hao, Ph.D. in Medicine
Outcome results
None listed