A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
NCT ID: NCT05761301
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
49 participants
INTERVENTIONAL
2023-03-10
2025-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Part A: ALN-KHK
Participants will be administered a single dose of ALN-KHK.
ALN-KHK
ALN-KHK will be administered by subcutaneous (SC) injection.
Part A: Placebo
Participants will be administered a single dose of placebo.
Placebo
Placebo will be administered by subcutaneous (SC) injection.
Part B: ALN-KHK
Participants will be administered a multiple doses of ALN-KHK.
ALN-KHK
ALN-KHK will be administered by subcutaneous (SC) injection.
Part B: Placebo
Participants will be administered a multiple doses of placebo.
Placebo
Placebo will be administered by subcutaneous (SC) injection.
Interventions
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ALN-KHK
ALN-KHK will be administered by subcutaneous (SC) injection.
Placebo
Placebo will be administered by subcutaneous (SC) injection.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Part A: History of Type 1 or Type 2 diabetes
* Part B: History of Type 1 diabetes
18 Years
65 Years
ALL
Yes
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
Vista, California, United States
Clinical Trial Site
Lake Worth, Florida, United States
Clinical Trial Site
Orlando, Florida, United States
Clinical Trial Site
Atlanta, Georgia, United States
Clinical Trial Site
Berlin, New Jersey, United States
Clinical Trial Site
Monroe, North Carolina, United States
Clinical Trial Site
Oklahoma City, Oklahoma, United States
Clinical Trial Site
Dallas, Texas, United States
Clinical Trial Site
Houston, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
Sarnia, Ontario, Canada
Clinical Trial Site
Montreal, Quebec, Canada
Clinical Trial Site
Victoriaville, Quebec, Canada
Clinical Trial Site
Toronto, , Canada
Countries
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Other Identifiers
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ALN-KHK-001
Identifier Type: -
Identifier Source: org_study_id
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