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

Ascletis Pharma (China) Co., Limited

Status and phase: Completed; Phase 1

Conditions: Chronic Weight Management

Treatments: Drug: ASC47 +Semaglutide; Drug: Placebo+Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06972992

ASC47-103

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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28 participants in 3 patient groups

Combo Cohort 1 in participants with obesity

Experimental group

Description:

Cohort 1, dose 1

Treatment:

Drug: Placebo+Semaglutide

Drug: ASC47 +Semaglutide

Combo Cohort 2 in participants with obesity

Experimental group

Description:

Cohort 2, dose 2

Treatment:

Drug: Placebo+Semaglutide

Drug: ASC47 +Semaglutide

Combo Cohort 3 in participants with obesity

Experimental group

Description:

Cohort 3, dose 3

Treatment:

Drug: Placebo+Semaglutide

Drug: ASC47 +Semaglutide