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OpenTrials
Completed

NCT Number: NCT06972992

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ascletis Clinical Site

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASC47 +Semaglutide

Drug

ASC47 single subcutaneous injection + Semaglutide QW for 4 weeks

Placebo+Semaglutide

Drug

Placebo single subcutaneous injection + Semaglutide QW for 4 weeks

Primary outcomes

  1. Adverse events

    Time frame: up to 71 days

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

Secondary outcomes

  1. Change From Baseline in Body Weight

    Time frame: up to 71 days

    Change from baseline (week 1) to week 10 in body weight was evaluated

  2. Cmax of ASC47

    Time frame: up to 71 days

    Evaluate the Peak Plasma Concentration of ASC47 in combination with semaglutide.

  3. AUC of ASC47

    Time frame: up to 71 days

    Evaluate the Area under the plasma concentration versus time curve of ASC47 in combination with semaglutide.

  4. T1/2 of ASC47

    Time frame: up to 71 days

    Evaluate the Terminal-Phase Half-Life of ASC47 in combination with semaglutide.

  5. CL/F of ASC47

    Time frame: up to 71 days

    Evaluate the Apparent Systemic Clearance of ASC47 in combination with semaglutide.

Sponsors and collaborators

Lead sponsor

Ascletis Pharma (China) Co., Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 15, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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