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

NCT ID: NCT06972992

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-18

Study Completion Date

2025-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Weight Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Combo Cohort 2 in participants with obesity

Cohort 2, dose 2

Group Type EXPERIMENTAL

ASC47 +Semaglutide

Intervention Type DRUG

ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks

Placebo+Semaglutide

Intervention Type DRUG

Placebo single subcutaneous injection + Semaglutide QW for 4 weeks

Combo Cohort 3 in participants with obesity

Cohort 3, dose 3

Group Type EXPERIMENTAL

ASC47 +Semaglutide

Intervention Type DRUG

ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks

Placebo+Semaglutide

Intervention Type DRUG

Placebo single subcutaneous injection + Semaglutide QW for 4 weeks

Combo Cohort 1 in participants with obesity

Cohort 1, dose 1

Group Type EXPERIMENTAL

ASC47 +Semaglutide

Intervention Type DRUG

ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks

Placebo+Semaglutide

Intervention Type DRUG

Placebo single subcutaneous injection + Semaglutide QW for 4 weeks

Interventions

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ASC47 +Semaglutide

ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks

Intervention Type DRUG

Placebo+Semaglutide

Placebo single subcutaneous injection + Semaglutide QW for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ascletis Pharma (China) Co., Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ascletis Clinical Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ASC47-103

Identifier Type: -

Identifier Source: org_study_id