What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as GLP-1 receptor agonists, insulin, and oral antihyperglycemic agents, have several known side effects. GLP-1 receptor agonists can cause gastrointestinal issues, pancreatitis, and potentially increase the risk of pancreatic cancer and cholelithiasis. Insulin therapy is associated with hypoglycemia and weight gain. Oral antihyperglycemic agents, like metformin, may cause gastrointestinal disturbances and, in rare cases, lactic acidosis. Cardiovascular outcomes vary, with some treatments showing benefits while others may pose risks.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes, including GLP-1 receptor agonists such as liraglutide, extended-release exenatide, and dulaglutide. These drugs work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying. Liraglutide and extended-release exenatide have been approved for use in children aged 10 years and older. Additionally, metformin and insulin are commonly used treatments, often in combination to improve glycemic control. These approvals highlight the ongoing efforts to provide effective pharmacologic options for managing Type 2 Diabetes.

What other types of research exist?

Promising novel alternatives for Type 2 Diabetes treatment in 2024 include GLP-1 receptor agonists (e.g., liraglutide, semaglutide, dulaglutide), SGLT2 inhibitors (e.g., empagliflozin, canagliflozin, dapagliflozin), and DPP-4 inhibitors (e.g., alogliptin). Additionally, glucokinase activators are emerging as a novel class with potential benefits in increasing insulin secretion and improving hepatic glucose metabolism.

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RNAi Therapeutics

ALN-KHK for Type 2 Diabetes

Q: What is the mechanism of action of this treatment?

Common treatments for Type 2 Diabetes include incretin-based therapies, SGLT2 inhibitors, and insulin therapy. Incretin-based therapies, such as GLP-1 receptor agonists, enhance insulin secretion and inhibit glucagon release in response to meals, aiding in blood glucose regulation. SGLT2 inhibitors work by preventing glucose reabsorption in the kidneys, leading to increased glucose excretion in the urine. Insulin therapy supplements or replaces the body's insulin, promoting glucose uptake by cells. These mechanisms are vital for managing blood glucose levels, reducing the risk of complications, and allowing for personalized treatment plans.

Phase 1 & 2

Recruiting

Research Sponsored by Alnylam Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Part B: BMI ≥32 kg/m^2 to ≤39.9 kg/m^2, confirmed diagnosis of T2DM, and an HbA1c ≥7.5% to <10%

Be older than 18 years old

Must not have

Part A: History of Type 1 or Type 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions typical to medication trials such as discomfort at injection site, nausea, headaches or dizziness. Since this is early-stage research (Phase 1/2), part of the study's purpose is to identify any additional side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include incretin-based therapies, SGLT2 inhibitors, and insulin therapy. Incretin-based therapies, such as GLP-1 receptor agonists, enhance insulin secretion and inhibit glucagon release in response to meals, aiding in blood glucose regulation. SGLT2 inhibitors work by preventing glucose reabsorption in the kidneys, leading to increased glucose excretion in the urine. Insulin therapy supplements or replaces the body's insulin, promoting glucose uptake by cells. These mechanisms are vital for managing blood glucose levels, reducing the risk of complications, and allowing for personalized treatment plans.

The Mystery of Diabetic Cardiomyopathy: From Early Concepts and Underlying Mechanisms to Novel Therapeutic Possibilities.What next after basal insulin? Treatment intensification with lixisenatide in Asian patients with type 2 diabetes mellitus.Combination therapy for the improvement of long-term macrovascular and microvascular outcomes in type 2 diabetes: Rationale and evidence for early initiation.