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RNAi Therapeutics

ALN-KHK for Type 2 Diabetes

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 part a: screening up to month 3; part b: month 4
Awards & highlights

Summary

This trial tests how safe and effective a drug is and how it works in the body when given in single or multiple doses.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~part a: screening up to month 3; part b: month 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: screening up to month 3; part b: month 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Frequency of Adverse Events
Part B: Frequency of Adverse Events
Secondary outcome measures
Part A: Area Under the Concentration-time Curve (AUC) of ALN-KHK and Potential Major Metabolite(s)
Part A: Fraction of ALN-KHK Excreted in the Urine (fe) and Potential Major Metabolite(s)
Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-KHK and Potential Major Metabolite(s)
+9 more

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.

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
74 Previous Clinical Trials
14,894 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,801 Previous Clinical Trials
8,070,170 Total Patients Enrolled

Media Library

ALN-KHK (RNAi Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT05761301 — Phase 1 & 2
Type 2 Diabetes Research Study Groups: Part B: ALN-KHK, Part B: Placebo, Part A: ALN-KHK, Part A: Placebo
Type 2 Diabetes Clinical Trial 2023: ALN-KHK Highlights & Side Effects. Trial Name: NCT05761301 — Phase 1 & 2
ALN-KHK (RNAi Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05761301 — Phase 1 & 2
~69 spots leftby Jul 2025