ALN-KHK for Type 2 Diabetes

Recruiting at 20 trial locations

Overseen By Alnylam Clinical Trial Information Line

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Alnylam Pharmaceuticals

Disqualifiers: Type 1 diabetes, investigational agent, others

Compensation: Varies

Number of Visits: Unknown

49 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called ALN-KHK to see how safe it is and how the body processes it. They are also testing another drug called KHK to check its safety and effectiveness. The study targets patients who might benefit from these drugs, aiming to understand their safety and how they work in the body.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug ALN-KHK work differently for type 2 diabetes?

ALN-KHK is unique because it targets ketohexokinase (KHK), an enzyme involved in fructose metabolism, which is not a common target in existing diabetes treatments. This approach may help address metabolic issues related to fructose, potentially offering a novel way to manage type 2 diabetes. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Alnylam Pharmaceuticals

Eligibility Criteria

This trial is for overweight to obese healthy individuals and those with Type 2 Diabetes Mellitus (T2DM). Healthy participants need a BMI between 27-34.9, while T2DM patients require a BMI of 32-39.9, an HbA1c level of at least 7.5% but less than 10%, and stable thyroid function without recent changes.

Inclusion Criteria

Your body mass index (BMI) is between 27 and 34.9.

My thyroid condition has been stable with no changes for at least 4 months.

My BMI is between 32 and 39.9, I have type 2 diabetes, and my HbA1c is between 7.5% and 10%.

Exclusion Criteria

I have a history of either Type 1 or Type 2 diabetes.

You have a history of type 1 diabetes.

You have used an experimental drug in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single ascending dose of ALN-KHK or placebo

1 week

Treatment Part B

Participants receive multiple doses of ALN-KHK or placebo

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ALN-KHK

Trial Overview The study tests ALN-KHK against a placebo in two parts: one focusing on safety and how the body processes single doses in healthy volunteers, and another looking at multiple doses' safety, tolerability, and effectiveness in obese T2DM patients.

Participant Groups

Group I: Part B: ALN-KHK Experimental Treatment 1 Intervention

Participants will be administered a multiple doses of ALN-KHK.

Group II: Part A: ALN-KHK Experimental Treatment 1 Intervention

Participants will be administered a single dose of ALN-KHK.

Group III: Part B: Placebo Placebo Group 1 Intervention

Participants will be administered a multiple doses of placebo.

Group IV: Part A: Placebo Placebo Group 1 Intervention

Participants will be administered a single dose of placebo.

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

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of MK-0941, a novel glucokinase activator, on glycemic control in insulin-treated patients with type 2 diabetes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Structure and alternative splicing of the ketohexokinase gene. [2019]

4. China pubmed.ncbi.nlm.nih.gov

Fructose and fructose kinase in cancer and other pathologies. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of compound K on hyperglycemia and insulin resistance in rats with type 2 diabetes mellitus. [2022]