Evaluating ASC47 with Semaglutide for weight management

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

This study is testing if a new combination of ASC47 and Semaglutide can help people who have trouble managing their weight feel better and achieve their goals.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ascletis Pharma Inc (industry)
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT06972992 on ClinicalTrials.gov

What this trial studies

This phase I clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC47 when combined with Semaglutide in individuals struggling with chronic weight management. The study will be conducted in three distinct periods: screening, treatment, and follow-up, utilizing a randomized, double-blind, placebo-controlled methodology. Participants will receive either the combination of ASC47 and Semaglutide or a placebo with Semaglutide to evaluate the effects of the treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with stable body weight who are not pregnant or breastfeeding and are willing to use effective contraceptive measures.

Not a fit: Patients with obesity due to medical causes or specific endocrinologic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for individuals seeking effective weight management solutions.

How similar studies have performed: While this approach is novel, similar studies have shown promise in combining pharmacological treatments for weight management.

Eligibility criteria

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.

Where this trial is running

San Antonio, Texas

• Ascletis Clinical Site — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Yvonne Li, MD

Conditions: Chronic Weight Management