Not yet recruitingPHASE1INTERVENTIONAL

A Study to Evaluate ALN-6222 in Participants With Obesity

This study is investigating a new medication called ALN-6222 for adults living with obesity. It's the first time this drug is being tested in humans. Researchers want to understand if it's safe, how the body handles it, and if it has any effect on weight. Participants will receive either ALN-6222 or a placebo (a dummy treatment) by injection under the skin. This helps scientists compare the real drug's effects. The study also looks at how well the body uses the drug and if it causes any changes within the body. It's a closely monitored study to ensure participant safety and gather important information about this potential new treatment.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

Alnylam Pharmaceuticals

Enrolment target

Start

03 Jun 2026

Estimated completion

14 Dec 2027

Obesity

What is this study about?

This research is focused on a new medication, known as ALN-6222, for people who are living with obesity. Being obese means having a very high amount of body fat, which can affect your health in many ways. Scientists are always looking for new ways to help manage obesity and improve overall health.

This particular study is a very early stage trial, often called a 'Phase 1' study. This means it's the first time ALN-6222 is being given to people. The main goal at this stage isn't to cure a condition, but to carefully check if the medication is safe to use and how the body reacts to it. They will also look at how much of the medication stays in the body and for how long, and if it seems to have any impact on the body's systems.

Participants will be randomly chosen to receive either the active medication (ALN-6222) or a placebo, which looks exactly like the medication but contains no active drug. This is important for comparing effects fairly. The medication will be given as an injection under the skin. This study is crucial for deciding whether ALN-6222 is safe and promising enough to continue testing in larger studies.

Key takeaways

This is a new study for an investigational medication, ALN-6222, for obesity.
It's a very early-stage trial (Phase 1) focused on safety and how the body handles the drug.
Participants will receive either the study drug or a placebo by injection.
You need to be an adult (18-65) with a specific BMI to be eligible.
Careful health checks and monitoring will be part of the study.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old. You must also have a Body Mass Index (BMI) that shows you are in the obesity range, specifically between 30 and less than 40. Your blood sugar control, measured by a test called HbA1c, should be good, meaning it's less than 6.5%.

However, some health conditions would mean you can't take part. For example, if you have certain liver problems, measured by specific blood tests (ALT or AST levels), you wouldn't be eligible. Also, if you have known HIV, hepatitis C, or hepatitis B infections, you wouldn't be able to join.

Finally, if your kidney function, measured by a test called eGFR, is lower than a certain level (less than 60 mL/min/1.73m^2), you would not be able to participate. There may be other specific reasons mentioned by the study team that would affect your eligibility.

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 between 18 and 65 years old?
Is your Body Mass Index (BMI) between 30 and less than 40?
Is your long-term blood sugar level (HbA1c) less than 6.5%?
Do you have certain liver or kidney conditions?
Do you have known HIV, Hepatitis C, or Hepatitis B?
Are you willing to receive injections under the skin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the study medication (ALN-6222) or a placebo. This will be given as an injection just under your skin. Because this is a very early study, you would be carefully monitored by the research team. This means you would likely have several visits to the clinic for health checks, blood tests, and to see if the medication is causing any side effects or changes in your body. The exact number of visits, tests, and the total length of the study would be fully explained by the research team, but the purpose is to gather as much information as possible on how the medication works and if it's safe. There will also be follow-up appointments after you stop taking the treatment to check on your health.

Potential risks and benefits

Potential benefits of joining this study include contributing to medical research and potentially being among the first to receive a new medication that might help with weight management, although benefits are not guaranteed, especially in early-stage studies. Risks could include side effects from the medication, discomfort from injections or blood tests, or unforeseen reactions. The research team will explain all known potential risks in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Clinical Trial Site
Verified postcode
Mount Royal, Canada

Common questions

What is a 'Phase 1' study?

It's the first stage of testing a new medication in people. The main goals are to check if it's safe, how the body handles it, and what side effects it might cause.

What does 'placebo-controlled' mean?

It means some people will get the real medication, and others will get a 'dummy' treatment (placebo) that looks the same but has no active drug. This helps scientists compare the effects fairly.

How will the medication be given?

The medication, or placebo, will be given as an injection just under the skin.

What is 'obesity' in this study?

In this study, obesity means having a Body Mass Index (BMI) between 30 and less than 40.

Can I stop participating if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your medical care.

How to find out more

Alnylam Clinical Trial Information Line

clinicaltrials@alnylam.com 1-877-ALNYLAM Official trial record

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