A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide
- Conditions
- Chronic Weight Management
- Interventions
- Drug: ASC47 +SemaglutideDrug: Placebo+Semaglutide
- Registration Number
- NCT06972992
- Lead Sponsor
- Ascletis Pharma (China) Co., Limited
- Brief Summary
This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Subject have provided informed consent before initiation of any study specific procedures
- Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
- No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, e.g., Clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia as assessed by the Investigator (or sub-I).
- Stable body weight (less than 5% self-reported change within the previous 3 months)
- Have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, Cushing syndrome, Prader-Willi syndrome and other conditions.
- Have a history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 half-lives of the experimental agent (exception of placebo) prior to the start of the treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Combo Cohort 1 in participants with obesity ASC47 +Semaglutide Cohort 1, dose 1 Combo Cohort 1 in participants with obesity Placebo+Semaglutide Cohort 1, dose 1 Combo Cohort 2 in participants with obesity ASC47 +Semaglutide Cohort 2, dose 2 Combo Cohort 2 in participants with obesity Placebo+Semaglutide Cohort 2, dose 2 Combo Cohort 3 in participants with obesity ASC47 +Semaglutide Cohort 3, dose 3 Combo Cohort 3 in participants with obesity Placebo+Semaglutide Cohort 3, dose 3
- Primary Outcome Measures
Name Time Method Adverse events up to 71 days Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Body Weight up to 71 days Change from baseline (week 1) to week 10 in body weight was evaluated
Cmax of ASC47 up to 71 days Evaluate the Peak Plasma Concentration of ASC47 in combination with semaglutide.
AUC of ASC47 up to 71 days Evaluate the Area under the plasma concentration versus time curve of ASC47 in combination with semaglutide.
T1/2 of ASC47 up to 71 days Evaluate the Terminal-Phase Half-Life of ASC47 in combination with semaglutide.
CL/F of ASC47 up to 71 days Evaluate the Apparent Systemic Clearance of ASC47 in combination with semaglutide.
Trial Locations
- Locations (1)
Ascletis Clinical Site
🇺🇸San Antonio, Texas, United States