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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
Stable euthyroid status (no known changes in thyroid function; stable hormone replacement for at least 4 months) at screening
Part B: BMI ≥32 kg/m^2 to ≤39.9 kg/m^2, confirmed diagnosis of T2DM, and an HbA1c ≥7.5% to <10%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study 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
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My thyroid condition has been stable with no changes for at least 4 months.
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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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I was diagnosed with type 2 diabetes less than 8 years ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months 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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alnylam PharmaceuticalsLead Sponsor
72 Previous Clinical Trials
14,658 Total Patients Enrolled
Medical DirectorStudy DirectorAlnylam Pharmaceuticals
2,777 Previous Clinical Trials
8,063,320 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment presently open for enrollment?

"According to clinicaltrials.gov, this experiment is searching for participants with the most recent update being made on March 7th of 2023. The trial was initially posted three months prior, in the first days of March."

Answered by AI

Are candidates aged 45 and above eligible for this trial?

"This research study requires participants to fall within the age bracket of 18 and 65. Additionally, there are 244 trials for children under 18 years old and 1282 trials for senior citizens over 65."

Answered by AI

What criteria must be fulfilled for someone to join this research?

"Patients with type 2 diabetes who fall between the age brackets of 18 to 65 can be admitted into this clinical trial. A total of 160 people are anticipated to take part in the study."

Answered by AI

How many participants are encompassed in this clinical investigation?

"Affirmative, clinicaltrials.gov attests to the ongoing recruitment of patients for this trial which was initially posted on March 1st 2023 and most recently updated on July 3rd 2023. 160 participants must be located from a single centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
2023. "A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05761301.
~11 spots leftby Jun 2024
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