1560 Participants NeededMy employer runs this trial

ASC30 for Obesity and Type 2 Diabetes

(AURORA-2 Trial)

Recruiting at 117 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ascletis Pharma (China) Co., Limited
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
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 a new treatment called ASC30, a potential drug for obesity and Type 2 Diabetes (T2DM). Researchers aim to determine if ASC30 is safe and effective over a long period compared to a placebo, which contains no active medicine. The study includes different groups, with some participants taking ASC30 and others taking the placebo. Individuals who have struggled to lose weight and have been diagnosed with T2DM might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that ASC30 is likely to be safe for humans?

A previous study did not share specific information about ASC30's safety. However, the trial under consideration is in its third phase. This indicates that earlier studies have shown ASC30 is likely safe enough for more people to try. By reaching this phase, ASC30 has already been tested on smaller groups. Researchers are confident in its safety to test it on more participants. This trial will help confirm how well ASC30 works for treating obesity and type 2 diabetes.12345

Why do researchers think this study treatment might be promising for obesity and type 2 diabetes?

Unlike the standard treatments for obesity and type 2 diabetes, which often include medications like metformin or GLP-1 receptor agonists, ASC30 is unique because it might offer a novel mechanism of action. Researchers are excited about ASC30 because it targets specific metabolic pathways that could enhance weight loss and improve blood sugar control more effectively. Additionally, ASC30 is administered orally, which could make it a more convenient option compared to injectable therapies. This innovative approach has the potential to address the underlying causes of these conditions, offering hope for better management and improved patient outcomes.

What evidence suggests that ASC30 might be an effective treatment for obesity and type 2 diabetes?

Research has shown that ASC30 may benefit people with obesity and type 2 diabetes. In earlier studies, participants taking ASC30 lost more weight than those on a placebo. These studies also found that ASC30 improved blood sugar levels, crucial for managing type 2 diabetes. Participants in this trial will receive ASC30 in one of the experimental cohorts, while others will receive a placebo. The treatment affects how the body controls hunger and insulin, the hormone that manages blood sugar. Early results suggest that ASC30 could be a promising option for improving weight and blood sugar control in people with these conditions.678910

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) who are overweight or obese (BMI of 27 or higher), have type 2 diabetes, and have tried but failed to lose weight through diet at least once. Their blood sugar levels must be moderately high but not extremely uncontrolled.

Inclusion Criteria

I am at least 18 years old or the legal age of consent.
My BMI is 27 or higher.
I have tried at least once to lose weight through dieting without success.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-daily oral ASC30 or placebo to evaluate long-term efficacy, safety, and tolerability

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ASC30

Trial Overview

The study tests a new daily oral medication called ASC30 in different doses versus a placebo (inactive pill) to see if it helps people with obesity or overweight and type 2 diabetes manage their weight and health over the long term. Participants are randomly assigned to groups without knowing which treatment they get.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: ASC30 Cohort 3Experimental Treatment1 Intervention
Group II: ASC30 Cohort 2Experimental Treatment1 Intervention
Group III: ASC30 Cohort 1Experimental Treatment1 Intervention
Group IV: Placebo Cohort 4Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ascletis Pharma (China) Co., Limited

Lead Sponsor

Trials
3
Recruited
180+

Citations

DATA Definition & Meaning

The meaning of DATA is factual information (such as measurements or statistics) used as a basis for reasoning, discussion, or calculation.

Amazon Data Request page

No information is available for this page.

3.

data.gov

data.gov/

Data.gov Home - Data.gov

Here you will find data, tools, and resources to conduct research, develop web and mobile applications, design data visualizations, and more.

Data

The OECD data pillar gathers all OECD data outputs from trusted statistics or indicators to interactive tools, dashboards and statistical releases

Federal Student Loan Portfolio

The reports below provide information about the federal student loan portfolio. Federal Student Aid Portfolio Summary · Federal Student Aid Portfolio by Loan ...

Screen Media Exposure and Obesity in Children ... - PMC - NIH

Many observational studies find relationships between screen media exposure and increased risks of obesity. Current evidence suggests that screen , purchase ...

Rich Homie Quan - Type of Way

From the album, "Still Goin In. Available now on iTunes! Walk Thru ft. Problem (Official Video) Differences (Official Video)

Future, Metro Boomin, Travis Scott, Playboi Carti

Future, Metro Boomin, Travis Scott, Playboi Carti - Type Shit (Official Video). @FutureVEVO1.2M likes152M views2 years ago

Sleep and obesity - PMC - NIH

This review summarizes the most recent evidence linking decreased sleep duration and poor sleep quality to obesity, focusing upon studies in adults.

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34455267/

Consumption of ultra-processed foods associated with ...

lowest quintile of UPF consumption was associated with a 15% greater risk (95% CI 1·11, 1·19) of becoming overweight or obese in normal weight participants, and ...