A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
This research study is looking at a new daily tablet called ASC30. It's for adults who are either living with obesity or are overweight and also have other health issues linked to their weight, such as high blood pressure or high cholesterol. The main goal is to find out if ASC30 can help people lose weight effectively and safely over a long time. Some participants will receive the new tablet, while others will get a 'dummy' pill (placebo) – neither they nor their doctors will know which one they are taking. This is a large study happening in many places, and it’s in the final stage of testing before a medicine might be approved for wider use. It's important for understanding new ways to manage weight.
At a glance
What is this study about?
This study is testing a new daily tablet called ASC30, which is being developed to help adults manage their weight. It's for people who are living with obesity, or those who are overweight and also have other health conditions often linked to weight, like high blood pressure, high cholesterol, or sleep apnea.
The main aim is to see if ASC30 is effective at helping people lose weight and keep it off. We also want to understand if it's safe to use over a longer period. This is a large, important study that takes place in many different countries. It's a 'Phase 3' study, which means it's one of the final steps in testing a new medicine before it might become available more widely.
Participants in the study will be randomly assigned to either receive the new ASC30 tablet or a placebo (a dummy pill that looks exactly like the real one but has no active medicine). Neither the participants nor their study doctors will know who is getting which treatment. This is a common and important way to ensure the results are fair and accurate, so we can clearly see if ASC30 is making a real difference compared to not taking any active medicine.
Key takeaways
- This study is testing a new daily tablet (ASC30) for weight management.
- It's for adults living with obesity or who are overweight with related health issues.
- Participants will receive either ASC30 or a dummy pill (placebo).
- It's a long-term study to check effectiveness and safety.
- Regular health checks and support will be provided.
- You can leave the study at any time.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. You should either have a Body Mass Index (BMI) of 30 or higher (which is considered obesity), or a BMI of 27 or higher if you also have at least one weight-related health problem. These health problems could include high blood pressure, high cholesterol, sleep apnea, or certain heart conditions.
It's important that you have tried to lose weight through diet before, but haven't been successful. You won't be able to join if you have certain types of diabetes, or if you've had a big change in your weight (more than 5 kg or about 11 pounds) in the last three months. Also, if you have a history of pancreatitis, severe kidney problems, or certain thyroid conditions in your family, you likely won't be eligible. If you're currently in another research study, you also can't take part in this one.
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 30 or higher, or a BMI of 27 or higher with at least one weight-related health problem (like high blood pressure or high cholesterol)?
- Have you tried to lose weight through diet in the past but found it difficult?
- Do you have certain types of diabetes, a history of pancreatitis, or specific thyroid conditions?
- Have you had a sudden weight change (more than 5 kg/11 lbs) in the last three months?
- Are you currently taking part in another medical research study?
What does participation involve?
If you join the study, you'll be given either the new ASC30 tablet or a dummy pill to take once a day. You'll have regular visits to the clinic so the study team can check on your health, see how you're responding to the treatment, and ensure you're safe. These visits will involve health checks like measuring your weight, blood pressure, and taking blood samples.
You'll be asked to keep a record of how you're feeling and any changes you notice. The study will continue for a long period to properly understand the effects of the tablet. During this time, the study team will be there to support you and answer any questions. You can choose to leave the study at any time, for any reason, without it affecting your medical care.
Potential risks and benefits
Locations (120)
- AURORA-1 Clinical SiteVerified postcodeBirmingham, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodeHuntsville, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodePhoenix, United States· Recruiting
- AURORA-1 Clinical SiteVerified postcodeTempe, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodeTucson, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodeLittle Rock, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodeBanning, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodeChula Vista, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodeCovina, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodeGardena, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodeTarzana, United States· Not yet recruiting
- AURORA-1 Clinical SiteVerified postcodeTustin, United States· Not yet recruiting
Common questions
What is a 'dummy pill' or placebo?
A dummy pill (placebo) looks exactly like the actual medicine but contains no active ingredients. It's used in studies to fairly compare the new medicine's effects.
Will I know if I'm getting the real medicine or the dummy pill?
No, neither you nor your study doctor will know whether you are receiving ASC30 or the dummy pill. This helps keep the study fair and scientific.
What happens if the study medicine doesn't help me?
If you don't feel the study medicine is helping, or if you experience any side effects, you should discuss this with your study doctor. You can always choose to leave the study.
How long will I need to be in the study?
The study involves long-term use of the medication, so your participation will last for an extended period, which the study team will discuss with you.
Can I continue my regular medication during the study?
You should discuss all your current medications with the study team. They will advise if any need to be stopped or adjusted for the study.
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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