24 Participants NeededMy employer runs this trial

ALN-4324 for Type 2 Diabetes

AC
Overseen ByAlnylam Clinical Trial Information Line
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alnylam Pharmaceuticals
Must be taking: Metformin
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ALN-4324, an experimental therapy, to determine if it can improve insulin sensitivity in people with Type 2 Diabetes. Participants will receive either a single dose of ALN-4324 or a placebo, which contains no active drug. The goal is to assess whether this treatment can help the body use insulin more effectively. The trial seeks adults diagnosed with Type 2 Diabetes who have a BMI between 25 and 39.9, specific blood sugar levels, and are on a stable dose of metformin. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of metformin, but it doesn't specify if you need to stop other medications. If you're taking other drugs that affect glucose or insulin, you might need to stop those.

Is there any evidence suggesting that ALN-4324 is likely to be safe for humans?

Research has shown that ALN-4324 is generally safe and well-tolerated. Tests with healthy volunteers found that single doses of ALN-4324 did not cause major side effects. In studies involving people with type 2 diabetes, the treatment also appeared safe, with most participants not experiencing serious problems. While mild side effects can occur, they remain uncommon. Overall, existing evidence suggests ALN-4324 is safe for humans based on previous research.12345

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Unlike the standard of care for type 2 diabetes, which typically involves medications like metformin and insulin that work by controlling blood sugar levels, ALN-4324 offers a unique approach. It uses an innovative mechanism of action to potentially target the underlying causes of diabetes more directly. Researchers are excited because ALN-4324 might offer a new way to manage diabetes, possibly leading to improved outcomes with just a single dose. This could represent a significant advancement in diabetes care, providing a more convenient and potentially more effective treatment option.

What evidence suggests that ALN-4324 might be an effective treatment for Type 2 Diabetes?

Research has shown that ALN-4324 is designed to help people with Type 2 Diabetes by improving insulin utilization. In this trial, participants will receive either a single dose of ALN-4324 or a placebo. Studies have found that ALN-4324 can enhance the body's insulin response without causing weight gain, a common issue with other diabetes treatments. Early results suggest that even one dose can help the body manage blood sugar levels more effectively. While more research is needed, these initial findings offer promise for those with Type 2 Diabetes.12367

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Alnylam Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are overweight or obese (BMI between 25 and 39.9), have stable blood sugar control on metformin, and an HbA1c between 6.5% and less than 10.5%.

Inclusion Criteria

I am an adult diagnosed with type 2 diabetes.
* Has a body mass index (BMI) of ≥25 kg/m\^2 and \<39.9 kg/m\^2
I am taking a stable dose of metformin.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ALN-4324 or placebo

Single dose

Follow-up

Participants are monitored for changes in insulin sensitivity and other measures

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • ALN-4324

Trial Overview

The study tests a single dose of ALN-4324 compared to a placebo to see if it improves insulin sensitivity in people with type 2 diabetes. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ALN-4324Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alnylam Pharmaceuticals

Lead Sponsor

Trials
81
Recruited
16,100+

Dr. Yvonne Greenstreet

Alnylam Pharmaceuticals

Chief Executive Officer since 2021

MD from the University of Leeds, MBA from INSEAD

Dr. Pushkal Garg

Alnylam Pharmaceuticals

Chief Medical Officer since 2016

MD from Columbia University

Citations

A Study to Evaluate ALN-4324 in Overweight to Obese ...

The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers.

Alnylam's New Diabetes Study Puts Insulin Sensitivity in ...

ALN-4324 is an experimental drug from Alnylam designed to be given as a single shot under the skin. The goal is to boost insulin sensitivity and ...

3.

clinicaltrials.alnylam.com

clinicaltrials.alnylam.com/trials/6845202

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