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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• 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)

Locations
United States
Texas
Ascletis Clinical Site
RECRUITING
San Antonio
Contact Information
Primary
Yvonne Li, MD
yike.li@ascletis.com
13777602263
Time Frame
Start Date: 2025-04-18
Estimated Completion Date: 2025-12-18
Participants
Target number of participants: 24
Treatments
Experimental: Combo Cohort 1 in participants with obesity
Cohort 1, dose 1
Experimental: Combo Cohort 2 in participants with obesity
Cohort 2, dose 2
Experimental: Combo Cohort 3 in participants with obesity
Cohort 3, dose 3
Related Therapeutic Areas
Sponsors
Leads: Ascletis Pharma (China) Co., Limited

This content was sourced from clinicaltrials.gov