NCT06972992CompletedPhase 1
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection, for Subcutaneous Use in Combination With Semaglutide in Participants With Obesity
Ascletis Pharma (China) Co., Limited1 site in 1 country28 target enrollmentStarted: April 18, 2025Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Combo Cohort 1 in participants with obesity
Experimental
Cohort 1, dose 1
Intervention: ASC47 +Semaglutide (Drug)
Combo Cohort 1 in participants with obesity
Experimental
Cohort 1, dose 1
Intervention: Placebo+Semaglutide (Drug)
Combo Cohort 2 in participants with obesity
Experimental
Cohort 2, dose 2
Intervention: ASC47 +Semaglutide (Drug)
Combo Cohort 2 in participants with obesity
Experimental
Cohort 2, dose 2
Intervention: Placebo+Semaglutide (Drug)
Combo Cohort 3 in participants with obesity
Experimental
Cohort 3, dose 3
Intervention: ASC47 +Semaglutide (Drug)
Combo Cohort 3 in participants with obesity
Experimental
Cohort 3, dose 3
Intervention: Placebo+Semaglutide (Drug)
Outcomes
Primary Outcomes
Adverse events
Time Frame: up to 71 days
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Secondary Outcomes
- Change From Baseline in Body Weight(up to 71 days)
- Cmax of ASC47(up to 71 days)
- AUC of ASC47(up to 71 days)
- T1/2 of ASC47(up to 71 days)
- CL/F of ASC47(up to 71 days)
Investigators
Study Sites (1)
Loading locations...
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