A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus.
This research study is looking into a new medicine called AMG 133. It's for adults who are overweight or have obesity. Some participants may also have type 2 diabetes. The main goal is to find out if AMG 133 helps people lose weight and how much weight they lose over 52 weeks. Researchers will also be checking if the medicine is safe to use and how well people tolerate it. Different doses of the medicine will be tested, and some people will receive a dummy treatment (placebo) for comparison. This is a common way to properly test new medicines to make sure results are accurate and reliable.
At a glance
What is this study about?
This study is about a new medicine called AMG 133, which is being investigated as a possible treatment for adults who are overweight or have obesity. Some of the people taking part in the study may also have type 2 diabetes. The study aims to understand how effective this new medicine is at helping people lose weight over a period of 52 weeks (about a year). They will also be carefully watching for any side effects and how well people tolerate the medicine.
To make sure the results are fair and accurate, the study is designed in a special way. It's "randomized," meaning participants are randomly assigned to receive either the new medicine or a dummy treatment, called a placebo. It's also "double-blind," which means neither the participants nor their doctors will know who is receiving the actual medicine and who is receiving the placebo. This helps prevent any bias in the results. Different doses of AMG 133 will be tested to find the most suitable amount.
The main thing researchers want to find out is the percentage of body weight participants lose by week 52. They will also look at other health markers like blood sugar levels (important for those with diabetes), insulin levels, and cholesterol levels. They will also measure things like waist size and overall body composition (how much fat and muscle someone has) to get a full picture of how the medicine affects the body.
Key takeaways
- This study is testing a new medicine (AMG 133) for weight loss.
- It's for adults who are overweight or have obesity, some with type 2 diabetes.
- The study will last about one year (52 weeks).
- Some participants will get the actual medicine, others a dummy treatment (placebo).
- Researchers will check for weight loss, safety, and other health markers.
- You can leave the study at any time if you wish.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years or older.
You would be considered for this study if you are overweight or have obesity. This includes people who have type 2 diabetes and those who don't.
Further specific health checks will be carried out by the study team to make sure it's safe for you to take part and that you meet all the necessary requirements for the study. Both men and women are welcome to participate.
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?
- Are you currently overweight or have obesity?
- Are you willing to attend regular study appointments?
- Are you comfortable potentially receiving a placebo (dummy treatment)?
What does participation involve?
If you decide to take part, you would receive either the study medicine, AMG 133, or a placebo (a dummy treatment). You wouldn't know which one you are getting, and neither would your study doctor. Throughout the study, you would attend several appointments at the clinic. During these visits, the study team would take measurements of your weight, waist size, and blood pressure. You would also have blood tests to check things like your blood sugar, cholesterol, and other health markers. Some people might also have special scans (called DXA scans) to look at their body composition. The study aims to last for 52 weeks, with regular follow-up visits during this time. The full commitment and exact schedule of visits would be explained in detail by the study team.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedHungary
Common questions
What is a placebo?
A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It's used to compare against the real medicine to see if the new medicine really works.
What does 'double-blind' mean?
This means that neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps prevent bias and ensures the study results are reliable.
How long will I be in the study?
The main part of the study where you receive the treatment will last for 52 weeks (about one year).
Will I have to pay to join the study?
No, you should not have to pay to participate in the study. All study-related treatments and assessments are usually provided free of charge.
What if I change my mind about taking part?
You can withdraw from the study at any time, for any reason, without needing to explain why, and it 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.
Discussion
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