Status:
COMPLETED
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide
Lead Sponsor:
Ascletis Pharma (China) Co., Limited
Conditions:
Chronic Weight Management
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06972992
Start Date
April 18 2025
End Date
September 22 2025
Last Update
December 18 2025
Active Locations (1)
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1
Ascletis Clinical Site
San Antonio, Texas, United States, 78209