ASC30 for Weight Management

No longer recruiting at 5 trial locations

Overseen ByVanessa Wang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ascletis Pharma (China) Co., Limited

Disqualifiers: Diabetes, Autoimmune disease, Pancreatitis, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tablets called ASC30 to evaluate their effectiveness in weight management. Researchers aim to ensure these tablets are safe, effective, and easy to tolerate. Participants will be divided into groups, with some receiving ASC30 tablets and others a placebo (a pill that resembles the real thing but contains no active ingredients). This trial may suit individuals without significant health issues who are interested in managing their weight. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ASC30 tablets are generally safe for people. In earlier studies, ASC30 was well-tolerated, with most participants experiencing no major issues. Most side effects were mild to moderate and primarily affected the stomach. No serious problems were reported. This suggests that while some individuals might experience mild stomach issues, serious problems are unlikely.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about ASC30 because it offers a unique approach to weight management by potentially targeting metabolic pathways that current treatments do not. Most existing treatments focus on appetite suppression or fat absorption inhibition, but ASC30 might work differently by affecting the body's energy balance at a cellular level. This novel mechanism could lead to more efficient weight loss with possibly fewer side effects, making it a promising option for those who have not responded well to other treatments.

What evidence suggests that this trial's treatments could be effective for weight management?

Research has shown that ASC30 Tablets can aid in weight management. In earlier studies, participants taking ASC30 once daily lost up to 6.5% of their body weight in just 28 days, compared to those taking a placebo (a pill with no active ingredients). This indicates that the drug helped participants lose more weight than those not taking it. The tablets were also well-tolerated, meaning they are generally safe and easy to use. These findings suggest that ASC30 could be effective for individuals struggling to lose weight. Participants in this trial will receive either ASC30 tablets, ASC30 tablets A1, or a placebo to further evaluate these effects.¹ ² ⁴ ⁶ ⁷

Are You a Good Fit for This Trial?

This trial is for non-smoking adults aged 18-75 who are overweight or obese with related health issues. Participants must consent to study procedures and have no significant medical findings from exams, ECGs, or vital signs measurements.

Inclusion Criteria

Have provided informed consent before initiation of any study-specific procedures

I am between 18 and 75 years old and do not smoke.

No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures

Exclusion Criteria

I have been diagnosed with diabetes.

Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised

I have had pancreatitis before.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ASC30 tablets or placebo administered orally once daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

ASC30 Tablets
ASC30 Tablets A1

Trial Overview

The study tests the effectiveness, safety, and tolerability of two versions of ASC30 tablets compared to a placebo in managing weight. It's a phase IIa trial where participants are randomly assigned to receive either the test drug or placebo without knowing which one they're getting.