3003 Participants NeededMy employer runs this trial

ASC30 for Obesity

(AURORA-1 Trial)

Recruiting at 107 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 oral treatment called ASC30 to determine its effectiveness and safety for individuals with obesity or overweight conditions, excluding those with Type 2 Diabetes. The study compares three different doses of ASC30 to a placebo. It seeks participants with a BMI of 30 or more, or a BMI of 27 or more accompanied by conditions such as high blood pressure, cholesterol issues, sleep apnea, or heart disease, who have previously attempted and failed to lose weight through dieting. As a Phase 3 trial, ASC30 is in the final stage before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment for obesity.

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

Research has shown that ASC30, a pill for treating obesity, is generally safe and easy to manage. Previous studies indicated that ASC30 had a safety profile similar to other treatments of its kind. Importantly, no participants discontinued its use due to side effects. The most common side effects were mild stomach issues, which were less severe than those typically associated with similar drugs. Liver tests remained normal, indicating a positive outcome. Overall, ASC30 has demonstrated positive safety results, making it a promising option for weight loss.12345

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about ASC30 for obesity because it offers a potentially groundbreaking approach compared to current treatments, which typically include lifestyle changes, medications like orlistat or GLP-1 receptor agonists, and bariatric surgery. ASC30 is unique because it is an oral tablet that may target specific pathways in the body differently, potentially improving weight loss outcomes with fewer side effects. This new mechanism of action could provide a more effective and user-friendly option for individuals struggling with obesity, making it an exciting prospect for both patients and healthcare providers.

What evidence suggests that ASC30 might be an effective treatment for obesity?

Research has shown that ASC30, a weight loss aid, delivers promising results for people with obesity. In several studies, participants taking ASC30 lost between 6.3% and 7.5% of their body weight over a few weeks. One study found that 80% of those on a higher dose of ASC30 lost at least 5% of their body weight, compared to only 4.2% in the placebo group. These findings suggest that ASC30 could be an effective weight loss option for people without type 2 diabetes. In this trial, researchers will assign participants to different cohorts to receive either ASC30 or a placebo to further evaluate its effectiveness.23678

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) who are overweight or have obesity, and also have at least one weight-related health issue like high blood pressure, abnormal cholesterol, sleep apnea, or heart disease. Participants must have tried but failed to lose weight through diet before.

Inclusion Criteria

I am at least 18 years old or the legal age of consent.
I have high blood pressure.
I have a history of heart disease or heart failure (Class I-III).
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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 once-daily oral ASC30 or placebo to evaluate efficacy and safety

Long-term

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 compares a new daily pill called ASC30 in three different doses against a placebo (inactive pill) to see how well it helps with long-term weight loss and safety. Participants are randomly assigned to groups and neither they nor the researchers know which treatment they're getting.

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

Ascletis Announces Positive Topline Results from U.S. ...

ASC30 SQ depot formulation A1 achieved placebo-adjusted mean body weight loss of 2.7%, 5.5%, 6.3%, and 7.5% at week 4, week 8, week 12 and week ...

Ascletis says weight-loss data for ASC30 injection point to ...

weight loss of 6.3% at week 12 and 7.5% at week 16. reductions reached 6.4% three months after the final dose and was 5.8% at four months, ...

ASC30 / Ascletis

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants With Obesity (clinicaltrials.gov) Clinical • P2 ...

A full analysis of 28-Day MAD Study of Oral GLP-1R ...

Body weight changes from baseline were –6.3% The maximum body weight changes from baseline were -7.6% and -9.1% baseline was -4.8% for MAD

ASC-30 - Drug Targets, Indications, Patents

Obesity 30 ASC30 average daily dose 9.25 mg (Cohort 1 had four Positive 19 Feb 2025 ASC30 average daily dose 18 mg

Ascletis' Oral Small Molecule GLP-1, ASC30 ...

At the 13-week primary endpoint, ASC30 once-daily tablets showed dose-dependent placebo-adjusted mean body weight reductions of 5.4%, 7.0% and ...

Ascletis Pharma Inc.

-ASC30 oral tablet was generally safe and well tolerated. All adverse events (AEs) AST), and other liver enzymes were in normal ranges.

GLP-1 Oral Tablet Shows Favorable Safety Findings in ...

ASC30, an investigational oral, once daily tablet for patients with obesity, showed mean weight reductions from baseline of 4.3% and 6.3% ...