ALN-KHK for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Alnylam Pharmaceuticals

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.

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%.

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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.

Treatment Details

Interventions

ALN-KHK (RNAi Therapeutics)

Trial OverviewThe 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

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: ALN-KHKExperimental Treatment1 Intervention

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

Group II: Part A: ALN-KHKExperimental Treatment1 Intervention

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

Group III: Part B: PlaceboPlacebo Group1 Intervention

Participants will be administered a multiple doses of placebo.

Group IV: Part A: PlaceboPlacebo Group1 Intervention

Participants will be administered a single dose of placebo.