ASC30 Tablets for Type 2 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests ASC30 tablets to evaluate their effectiveness and safety for people with Type 2 Diabetes. Participants will receive varying doses of ASC30 tablets or a placebo (a pill with no active medicine) once daily. Eligible participants must have Type 2 Diabetes, a stable body weight, and a BMI of at least 23. This trial excludes individuals with Type 1 Diabetes, severe low blood sugar episodes, or uncontrolled high blood pressure. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important diabetes research.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that ASC30 tablets are being tested for safety in people with Type 2 Diabetes. Earlier studies examined how well participants tolerated these tablets. So far, results indicate that most people tolerate the treatment well. These studies have reported no major safety problems, and participants have not experienced significant side effects.
ASC30 tablets are easy to use, taken once a day by mouth. While detailed safety information is still being collected, these ongoing tests are crucial to ensure the tablets are safe and effective. Joining a trial will help gather more information about its safety.12345Why do researchers think this study treatment might be promising for Type 2 Diabetes?
Researchers are excited about ASC30 tablets for Type 2 Diabetes because they promise a novel approach compared to existing treatments. Most current diabetes medications, like metformin and sulfonylureas, work by increasing insulin sensitivity or production. ASC30, however, targets a different pathway that could improve glucose control in a new way. Additionally, the tablets are designed to be taken orally once daily, which is convenient and could improve patient adherence. This unique mechanism and ease of use give ASC30 the potential to offer better blood sugar management for people with Type 2 Diabetes.
What evidence suggests that ASC30 tablets could be an effective treatment for Type 2 Diabetes?
Research has shown that ASC30 tablets might benefit people with Type 2 diabetes. In earlier studies, patients who took ASC30 once daily lost a noticeable amount of weight. On average, they lost up to 6.5% more weight than those who took a placebo, and this occurred in just 28 days. Another study found that different doses of ASC30 led to weight losses of 5.4%, 7.0%, and 7.7%. These results suggest that ASC30 could aid in weight management, which is important for controlling Type 2 diabetes. While these studies mainly focus on weight loss, they offer hope for other benefits ASC30 might provide in treating Type 2 diabetes.35678
Are You a Good Fit for This Trial?
This trial is for individuals with Type 2 Diabetes Mellitus. Participants should meet certain health criteria, but specific inclusion and exclusion details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ASC30 tablets or placebo once daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ASC30 Tablets
Trial Overview
The study tests the effectiveness of ASC30 tablets compared to a placebo in managing Type 2 Diabetes. It's a Phase II trial where participants are randomly assigned to either the treatment or placebo group without knowing which one they receive.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive ASC30 tablets Dose 3 administered orally once daily.
Participants will receive ASC30 tablets Dose 2 administered orally once daily.
Participants will receive ASC30 tablets Dose 1 administered orally once daily.
Participants will receive Placebo administered orally once daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascletis Pharma (China) Co., Limited
Lead Sponsor
Citations
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 receives FDA approval for diabetes mellitus ...
The primary endpoint results showed dose-dependent, placebo-adjusted mean body weight reductions of 5.4%, 7.0%, and 7.7% for daily doses of 20mg ...
Ascletis Announces U.S. FDA IND Clearance for 13-Week ...
Secondary endpoints include the mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the ...
4.
trial.medpath.com
trial.medpath.com/clinical-trial/1dd8234ffb2a3fa3/nct07321678-asc30-tablets-type-2-diabetesA Study to Evaluate the Efficacy, Safety, and Tolerability of ...
This randomized, double-blind, placebo-controlled Phase II study is designed to evaluate the efficacy, safety, and tolerability of ASC30 ...
5.
clival.com
clival.com/news/ascletis-secures-fda-ind-clearance-for-oral-glp-1-asc30-in-type-2-diabetesAscletis Secures FDA IND Clearance for Oral GLP-1 ...
The diabetes study builds on recently completed 13-week Phase II obesity data for ASC30. Key obesity trial results. 125 participants with ...
A Study to Evaluate the Efficacy, Safety, and Tolerability of ...
Also called a data safety ... A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes ...
Ascletis Announces U.S. FDA IND Clearance for 13-Week ...
Secondary endpoints include the mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the ...
8.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-evaluate-the-efficacy-safety-and-tolerability-of-asc30-tablets-in-participants-with-typA Study to Evaluate the Efficacy, Safety, and Tolerability of ...
This randomized, double-blind, placebo-controlled Phase II study is designed to evaluate the efficacy, safety, and tolerability of ASC30 ...
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