A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes
This research is testing a new daily tablet called ASC30 for adults living in the UK who are overweight or have obesity and also have type 2 diabetes. The study aims to understand how effective and safe this new medicine is at helping with weight management over a longer period. It's a 'Phase 3' trial, which means it's a large study involving many people to confirm if the drug is good enough to be considered for wider use. Participants will either receive the active ASC30 tablet or a 'placebo' (a dummy pill with no medicine) to compare their effects. This helps researchers truly understand the benefits and any potential side effects of ASC30.
At a glance
What is this study about?
This study, known as AURORA-2, is investigating a new oral tablet called ASC30. It's designed for adults who are either overweight or have obesity, and also have type 2 diabetes. Many people with type 2 diabetes also face challenges with weight management, and this study aims to find out if ASC30 can be a safe and effective way to help with both.
The main goal is to see if taking ASC30 once a day helps people manage their weight over a long period, and to understand if it's safe to use. This is a 'Phase 3' study, which is a key stage where new treatments are tested in a large number of people before they can be considered for approval. By comparing ASC30 to a 'placebo' (a tablet that looks the same but contains no active medicine), researchers can accurately determine the real effects of ASC30.
Taking part in such a study contributes to medical knowledge and could potentially lead to new treatment options for people managing their weight alongside type 2 diabetes. All studies are carefully planned to protect participants and gather important information.
Key takeaways
- This study is for adults who are overweight or have obesity and type 2 diabetes.
- It's testing a new daily tablet called ASC30 for weight management and safety.
- Participants will either receive the new tablet or a dummy pill (placebo).
- It's a large, important 'Phase 3' study to gather key information.
- Your health will be carefully monitored throughout the study.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To join this study, you would need to be at least 18 years old. You should have a Body Mass Index (BMI) of 27 or higher, which indicates you are overweight or have obesity. It's also important that you've tried to lose weight with diet changes before, but haven't been successful.
Crucially, you must have been diagnosed with type 2 diabetes. Your recent blood test (HbA1c) for diabetes control needs to be within a specific range, showing your diabetes is not too well controlled but also not extremely high. You cannot have type 1 diabetes or other specific types of diabetes.
There are also some reasons why you might not be able to join. For example, if your weight has changed a lot in the last three months, if you have certain kidney problems, or if you've had pancreatitis. Also, if you're allergic to similar medications called GLP-1 RAs, or if you or a close family member has a history of certain thyroid cancers (medullary thyroid carcinoma) or a condition called MEN type 2, you wouldn't be able to participate. You also can't be in another clinical trial at the same time.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a BMI of 27 or higher (overweight or obesity)?
- Have you tried to lose weight with diet before without success?
- Do you have type 2 diabetes (not type 1 or other types)?
- Are your diabetes blood test (HbA1c) results within the specified range for the study?
- Do you *not* have a history of pancreatitis, severe kidney problems, or certain thyroid cancers in yourself or a close family member?
What does participation involve?
If you are eligible and choose to take part, you would be randomly assigned to either receive the new ASC30 tablet or a dummy pill (placebo). This means neither you nor the study team will know which one you are taking. You'll take your assigned tablet once a day.
You would have regular visits to the study clinic for check-ups, blood tests, and other assessments to monitor your health, how the treatment is working, and any side effects. The total length of the study isn't specified here, but Phase 3 trials often run for several months to a couple of years to properly assess long-term effects. You would be given clear instructions on your medication, diet, and what to expect throughout your time in the study.
Potential risks and benefits
Locations (136)
- AURORA-2 Clinical SiteVerified postcodeBirmingham, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodeHuntsville, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodePeoria, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodePhoenix, United States· Recruiting
- AURORA-2 Clinical SiteVerified postcodeTempe, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodeTucson, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodeLittle Rock, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodeBanning, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodeChula Vista, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodeCovina, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodeGardena, United States· Not yet recruiting
- AURORA-2 Clinical SiteVerified postcodeLa Mesa, United States· Not yet recruiting
Common questions
What is a 'Phase 3' study?
Phase 3 is a large study that tests a new medicine in many people to see if it's safe and works better than existing treatments or a dummy pill (placebo) before it can be considered for approval.
What does 'randomized, double-blind, placebo-controlled' mean?
This means you'll be randomly assigned to either the new medicine or a dummy pill. Neither you nor your study doctor will know which you are taking. This helps ensure fair and accurate results.
What is ASC30?
ASC30 is the name of the new tablet being tested in this study. It's an investigational medicine, meaning it's not yet available outside of clinical trials.
Will I have to pay to join the study?
No, you will not have to pay to participate in the study. All study-related medication and assessments will be provided.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any time and for any reason, without having to explain why. Your decision will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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