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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)
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
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
Start Date
March 10, 2023
Primary Completion Date
April 3, 2025
Completion Date
April 3, 2025
Last Updated
May 7, 2025
49
ACTUAL participants
ALN-KHK
DRUG
Placebo
DRUG
Lead Sponsor
Alnylam Pharmaceuticals
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04943861