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

NCT06972992 | Completed Phase 1 FDA Drug

• 1 other identifier: ASC47-103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Weight Management

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)

  up to 71 days

Secondary Outcomes (5)

• 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

Study Arms (3)

Combo Cohort 1 in participants with obesity

EXPERIMENTAL

Cohort 1, dose 1

Drug: ASC47 +Semaglutide; Drug: Placebo+Semaglutide

Combo Cohort 2 in participants with obesity

EXPERIMENTAL

Cohort 2, dose 2

Drug: ASC47 +Semaglutide; Drug: Placebo+Semaglutide

Combo Cohort 3 in participants with obesity

EXPERIMENTAL

Cohort 3, dose 3

Drug: ASC47 +Semaglutide; Drug: Placebo+Semaglutide

Interventions

ASC47 +Semaglutide DRUG

ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks

Combo Cohort 1 in participants with obesity; Combo Cohort 2 in participants with obesity; Combo Cohort 3 in participants with obesity

Placebo+Semaglutide DRUG

Placebo single subcutaneous injection + Semaglutide QW for 4 weeks

Combo Cohort 1 in participants with obesity; Combo Cohort 2 in participants with obesity; Combo Cohort 3 in participants with obesity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascletis Pharma (China) Co., Limited: lead

Study Sites (1)

Ascletis Clinical Site

San Antonio, Texas, 78209, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: April 18, 2025
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-09

Locations

US (1)