Evaluating ASC30 Injection for Weight Management

A Phase I/IIa, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Injection, for Subcutaneous Use in Participants With Obesity

This study is testing if an injection called ASC30 can help people with obesity manage their weight better compared to a placebo.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ascletis Pharma Inc (industry)
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT06679959 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and efficacy of ASC30 injection in individuals with obesity. It employs a randomized, double-blind, placebo-controlled approach, utilizing both single ascending dose (SAD) and multiple ascending dose (MAD) methodologies. Participants will receive either the ASC30 injection or a placebo to determine the treatment's effects on chronic weight management. The study aims to gather comprehensive data on how the injection interacts with the body and its potential benefits for weight loss.

Who should consider this trial

Good fit: Ideal candidates for this study are non-smoking adults aged 18 to 65 who do not have significant medical conditions.

Not a fit: Patients with a history of diabetes, autoimmune diseases, or significant chronic illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for effective weight management in individuals struggling with obesity.

How similar studies have performed: While there have been various studies on obesity treatments, the specific approach of ASC30 injection is novel and has not been extensively tested in this manner.

Eligibility criteria

Inclusion Criteria:

1. Have provided informed consent before initiation of any study-specific procedures.
2. Male or female participants, non-smokers, between 18 and 65 years of age (both inclusive).
3. No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.

Exclusion Criteria:

1. Have evidence of any clinically significant active or chronic disease.
2. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
3. Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
4. Have a history of acute or chronic pancreatitis.
5. Participants with a known clinically significant gastric emptying abnormality.
6. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
7. Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.

Where this trial is running

San Antonio, Texas

• Ascletis clinical site — San Antonio, Texas, United States (RECRUITING)

Conditions: Chronic Weight Management