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A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM

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ClinicalTrials.gov Identifier: NCT05761301
Recruitment Status : Recruiting
First Posted : March 9, 2023
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Study Description
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Brief Summary:
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Drug: ALN-KHK Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The single ascending dose part of this study (Part A) will have a sequential interventional study model. The multi-dose part of this study (Part B) will have a parallel interventional study model and will begin after the completion of Part A.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Randomized, Double-blind, Placebo-controlled, 2-Part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-KHK in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-KHK in Obese Patients With Type 2 Diabetes Mellitus (T2DM)
Actual Study Start Date : March 10, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: ALN-KHK
Participants will be administered a single dose of ALN-KHK.
 Drug: ALN-KHK
ALN-KHK will be administered by subcutaneous (SC) injection.
Placebo Comparator: Part A: Placebo
Participants will be administered a single dose of placebo.
 Drug: Placebo
Placebo will be administered by subcutaneous (SC) injection.
Experimental: Part B: ALN-KHK
Participants will be administered a multiple doses of ALN-KHK.
 Drug: ALN-KHK
ALN-KHK will be administered by subcutaneous (SC) injection.
Placebo Comparator: Part B: Placebo
Participants will be administered a multiple doses of placebo.
 Drug: Placebo
Placebo will be administered by subcutaneous (SC) injection.


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Frequency of Adverse Events [ Time Frame: Up to 9 Months ]
  2. Part B: Frequency of Adverse Events [ Time Frame: Up to 12 Months ]

Secondary Outcome Measures :
  1. Part A: Area Under the Concentration-time Curve (AUC) of ALN-KHK and Potential Major Metabolite(s) [ Time Frame: Up to 2 Days following dosing on Day 1 ]
  2. Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-KHK and Potential Major Metabolite(s) [ Time Frame: Up to 2 Days following dosing on Day 1 ]
  3. Part A: Time to Maximum Observed Plasma Concentration (Tmax) of ALN-KHK and Potential Major Metabolite(s) [ Time Frame: Up to 2 Days following dosing on Day 1 ]
  4. Part A: Fraction of ALN-KHK Excreted in the Urine (fe) and Potential Major Metabolite(s) [ Time Frame: Postdose on Day 1 ]
  5. Part A: Percent Change from Baseline in Circulating Fructose in Response to a Fructose Tolerance Test [ Time Frame: Baseline up to Month 6 ]
  6. Part A: Percent Change from Baseline in Urinary Fructose in Response to a Fructose Tolerance Test [ Time Frame: Baseline up to Month 6 ]
  7. Part A: Percent Change from Baseline in Circulating Fibroblast Growth Factor 21 (FGF21) in Response to a Fructose Tolerance Test [ Time Frame: Baseline up to Month 6 ]
  8. Part B: Absolute Change from Baseline in Hemoglobin A1C (HbA1c) at 6 Months [ Time Frame: Baseline and Month 6 ]
  9. Parts A and B: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) in Response to a Glucose Tolerance Test [ Time Frame: Part A: Screening up to Month 3; Part B: Month 4 ]
  10. Part B: Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Month 4 ]
  11. Parts A and B: Glucose and Insulin AUC in response to Tolerance Test [ Time Frame: Part A: Screening up to Month 3; Part B: Month 4 ]
  12. Part B: Plasma Concentrations of ALN-KHK and Potential Major Metabolite(s) [ Time Frame: Day 1 and Month 3 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Stable euthyroid status (no known changes in thyroid function; stable hormone replacement for at least 4 months) at screening
  • Part A: body mass index (BMI) ≥27 kg/m^2 and ≤34.9 kg/m^2
  • Part B: BMI ≥30 kg/m^2 to ≤39.9 kg/m^2, confirmed diagnosis of T2DM, and an HbA1c ≥7.5% to <10%
  • Part B: Confirmed T2DM diagnosis (≤8 years)

Exclusion Criteria:

  • Parts A and B: has received an investigational agent within the last 30 days
  • Part A: History of Type 1 or Type 2 diabetes
  • Part B: History of Type 1 diabetes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05761301


Contacts
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Contact: Alnylam Clinical Trial Information Line 1-877-ALNYLAM clinicaltrials@alnylam.com
Contact: Alnylam Clinical Trial Information Line 1-877-256-9526 clinicaltrials@alnylam.com

Locations
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United States, Florida
Clinical Trial Site Not yet recruiting
Lake Worth, Florida, United States, 33461
United States, Oklahoma
Clinical Trial Site Not yet recruiting
Oklahoma City, Oklahoma, United States, 73112
Canada, Ontario
Clinical Trial Site Recruiting
Sarnia, Ontario, Canada
Canada, Quebec
Clinical Trial Site Recruiting
Montréal, Quebec, Canada
Clinical Trial Site Recruiting
Victoriaville, Quebec, Canada
Sponsors and Collaborators
Alnylam Pharmaceuticals
Investigators
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Study Director: Medical Director Alnylam Pharmaceuticals
More Information
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Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05761301    
Other Study ID Numbers: ALN-KHK-001
First Posted: March 9, 2023    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alnylam Pharmaceuticals:
Overweight
Obese
Fructose
siRNA
 HbA1C
Insulin
Glucose
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight