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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate ALN-2232 in Participants With Obesity

This research study aims to understand a new medication, ALN-2232, developed for individuals with obesity. Researchers want to find out if ALN-2232 is safe, how people tolerate it, and if it can help with weight management. The study will look at different doses of ALN-2232 alone. It will also explore what happens when ALN-2232 is given together with an existing medicine called tirzepatide. By carefully watching participants, the team hopes to learn more about how this new medicine works in the body and if it could be a helpful option for weight loss in the future.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Alnylam Pharmaceuticals
Enrolment target
156
Start
02 Mar 2026
Estimated completion
02 Mar 2028

What is this study about?

This study is about a new medicine called ALN-2232, which is being tested for people who are living with obesity. Being overweight or obese can increase the risk of many health problems, so scientists are always looking for new and better ways to help people manage their weight.

The main goal of this study is to see if ALN-2232 is safe and well-tolerated by the body. They will be giving different doses to participants to understand how much can be given safely. The study will also be checking to see if this new medicine actually helps people to lose weight. They want to learn how the medicine behaves in the body and what effects it has.

In some parts of the study, ALN-2232 will be given on its own. In other parts, it will be given alongside another medicine called tirzepatide, which is already used to help with weight management. By doing this, researchers hope to understand if ALN-2232 could work even better if taken with other treatments.

Key takeaways

  • This study is testing a new medicine, ALN-2232, for obesity.
  • It aims to check the safety and how well the medicine works.
  • Some people will get ALN-2232 alone, others will get it with another medicine (tirzepatide), or a placebo.
  • You must be 18-65 years old with a specific BMI and good blood sugar levels.
  • Close monitoring will happen during regular clinic visits.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old. Your body mass index (BMI), which is a measure of your weight against your height, must be 30 or higher but less than 40. Your blood sugar levels, measured by something called HbA1c, should be normal and below 6.5%.

However, there are some reasons why you wouldn't be able to join. You can't take part if you have any other serious health problems that might make taking part risky or make it hard to understand the study results. You also can't be in the study if you are already taking other medicines specifically for long-term weight loss or for diabetes.

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.

  1. Are you between 18 and 65 years old?
  2. Is your BMI between 30 and less than 40?
  3. Are your blood sugar levels (HbA1c) below 6.5%?
  4. Are you NOT currently taking other medicines for long-term weight management or diabetes?
  5. Do you NOT have any other serious health conditions that might affect the study?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new study medicine, ALN-2232, a look-alike dummy medicine (placebo), or ALN-2232 along with tirzepatide. You won't know which one you're getting. You'll have regular visits to the clinic where the study team will carry out health checks, take blood samples, and ask you about how you are feeling. This helps them understand how the medicine is working and to make sure you are safe. The study will involve a number of visits over a period of time, and all your progress will be carefully tracked. The total duration of your participation will be explained in full detail by the study team.

Potential risks and benefits

Taking part in a study like this might have some potential benefits, such as getting access to a new medicine before it’s widely available, and your health will be closely monitored. However, there are also potential risks, like experiencing side effects from the study medicine, or the medicine might not work for you. You will be told about all known risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Clinical Trial Site
    Verified postcode
    Mount Royal, Canada· Recruiting

Common questions

What is obesity?

Obesity is a medical condition where you have too much body fat, which can lead to other health problems. Doctors often use a measure called BMI to determine if someone has obesity.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active ingredients. It's used to compare the effects of the real medicine.

What is tirzepatide?

Tirzepatide is a medicine that is already approved and used to help people manage their weight and blood sugar levels.

Will I know if I'm getting the new medicine or the placebo?

No, this is usually a 'blinded' study, meaning neither you nor the study doctors will know which treatment you are receiving until after the study is complete. This helps ensure fair results.

How long will I be in the study?

The exact length of your participation will be discussed in detail by the study team, but it will involve a series of visits over several weeks or months.

How to find out more

Alnylam Clinical Trial Information Line

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate ALN-2232 in Participants With Obesity…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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