A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide

Description

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.

Conditions

Chronic Weight Management

Study Overview

Study Details

Study overview

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.

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

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide

Condition
Chronic Weight Management
Intervention / Treatment

-

Contacts and Locations

San Antonio

Ascletis Clinical Site, San Antonio, Texas, United States, 78209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Ascletis Pharma (China) Co., Limited,

Study Record Dates

2025-12-18