125 Participants Needed

ASC30 for Weight Management

Recruiting at 5 trial locations
VW
Overseen ByVanessa Wang, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Ascletis Pharma (China) Co., Limited
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.12345

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.12467

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.
See 4 more

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.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Cohort 7Experimental Treatment1 Intervention
Group II: Cohort 6Experimental Treatment1 Intervention
Group III: Cohort 5Experimental Treatment1 Intervention
Group IV: Cohort 4Experimental Treatment1 Intervention
Group V: Cohort 3Experimental Treatment1 Intervention
Group VI: Cohort 2Experimental Treatment1 Intervention
Group VII: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ascletis Pharma (China) Co., Limited

Lead Sponsor

Trials
3
Recruited
180+

Citations

Ascletis Presents Full Analysis of Phase Ib Study of ASC30 ...Conclusion: ASC30 once-daily oral tablet demonstrated up to 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day ...
Ascletis Presented Results from Cohorts 1 and 2 of 28-day ...ASC30 once-daily oral tablet demonstrated up to 6.5% placebo-adjusted mean body weight reduction from baseline after 28-day treatment.
Ascletis' ASC30 Shows Strong PK Data and Weight Loss ...These results suggest that higher drug exposure correlates with greater weight loss, while ASC30's optimized chemistry improves tolerability.
Ascletis Pharma Inc.ASC30 oral tablet demonstrated dose-proportional pharmacokinetic (PK) properties and a long half-life (t1/2) up to 60 hours in the SAD study of ...
Ascletis Announces Positive Topline Results of U.S. Phase ...ASC30 oral once-daily tablet demonstrated a 6.5% placebo-adjusted mean body weight reduction from baseline after four-week treatment using weekly doses.
NCT07002905 | A Study to Evaluate the Efficacy, Safety ...This randomized, double-blind, placebo-controlled phase IIa study is designed to evaluate the efficacy, safety, and tolerability of ASC30 Tablets and ASC30 ...
ASC30 for Obesity · Info for ParticipantsWhat safety data exists for ASC30 treatment for obesity? The provided research does not contain specific safety data for ASC30 or any treatment under that name ...
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