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Clinical Trial Details

Trial ID: L3729
Source ID: NCT05761301
Associated Drug: Aln-Khk
Title: A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: ALN-KHK|DRUG: Placebo
Outcome Measures: Primary: Part A: Frequency of Adverse Events, Up to 9 Months|Part B: Frequency of Adverse Events, Up to 12 Months | Secondary: Part A: Area Under the Concentration-time Curve (AUC) of ALN-KHK and Potential Major Metabolite(s), Up to 2 Days following dosing on Day 1|Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-KHK and Potential Major Metabolite(s), Up to 2 Days following dosing on Day 1|Part A: Time to Maximum Observed Plasma Concentration (Tmax) of ALN-KHK and Potential Major Metabolite(s), Up to 2 Days following dosing on Day 1|Part A: Fraction of ALN-KHK Excreted in the Urine (fe) and Potential Major Metabolite(s), Postdose on Day 1|Part A: Percent Change from Baseline in Circulating Fructose in Response to a Fructose Tolerance Test, Baseline up to Month 6|Part A: Percent Change from Baseline in Urinary Fructose in Response to a Fructose Tolerance Test, Baseline up to Month 6|Part A: Percent Change from Baseline in Circulating Fibroblast Growth Factor 21 (FGF21) in Response to a Fructose Tolerance Test, Baseline up to Month 6|Part B: Absolute Change from Baseline in Hemoglobin A1C (HbA1c) at 6 Months, Baseline and Month 6|Parts A and B: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) in Response to a Glucose Tolerance Test, Part A: Screening up to Month 3; Part B: Month 4|Part B: Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), Month 4|Parts A and B: Glucose and Insulin AUC in response to Tolerance Test, Part A: Screening up to Month 3; Part B: Month 4|Part B: Plasma Concentrations of ALN-KHK and Potential Major Metabolite(s), Day 1 and Month 3
Sponsor/Collaborators: Sponsor: Alnylam Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 49
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-10
Completion Date: 2025-04-30
Results First Posted:
Last Update Posted: 2025-01-22
Locations: Clinical Trial Site, Phoenix, Arizona, 85020, United States|Clinical Trial Site, Vista, California, 92083, United States|Clinical Trial Site, Lake Worth, Florida, 33461, United States|Clinical Trial Site, Orlando, Florida, 32806, United States|Clinical Trial Site, Atlanta, Georgia, 30342, United States|Clinical Trial Site, Berlin, New Jersey, 08009, United States|Clinical Trial Site, Monroe, North Carolina, 28110, United States|Clinical Trial Site, Oklahoma City, Oklahoma, 73112, United States|Clinical Trial Site, Dallas, Texas, 75234, United States|Clinical Trial Site, Houston, Texas, 77036, United States|Clinical Trial Site, San Antonio, Texas, 78229, United States|Clinical Trial Site, Sarnia, Ontario, Canada|Clinical Trial Site, Montréal, Quebec, Canada|Clinical Trial Site, Victoriaville, Quebec, Canada|Clinical Trial Site, Toronto, Canada
URL: https://clinicaltrials.gov/show/NCT05761301