Chronic Weight Management
Conditions
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.
Interventions
DRUGASC47 +Semaglutide
ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks
DRUGPlacebo+Semaglutide
Placebo single subcutaneous injection + Semaglutide QW for 4 weeks
Sponsors
Ascletis Pharma (China) Co., Limited
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | up to 71 days | Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of ASC47 | up to 71 days | Evaluate the Area under the plasma concentration versus time curve of ASC47 in combination with semaglutide. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed