A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
Reason given: Business reasons (not safety related)
Key facts
- Where
- Atlanta, Berlin, Dallas, Houston, Lake Worth, Monroe, Oklahoma City, Orlando, Phoenix, San Antonio, and Vista, United StatesSee the 11 sites
- Phase
- Phase 1/2
Where in United States
- AtlantaAtlanta, United StatesNo longer taking part
- BerlinBerlin, United StatesNo longer taking part
- DallasDallas, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- Lake WorthLake Worth, United StatesNo longer taking part
- MonroeMonroe, United StatesNo longer taking part
- Oklahoma CityOklahoma City, United StatesNo longer taking part
- OrlandoOrlando, United StatesNo longer taking part
- PhoenixPhoenix, United StatesNo longer taking part
- San AntonioSan Antonio, United StatesNo longer taking part
- VistaVista, United StatesNo longer taking part
Trial details
- Who runs it
- Alnylam Pharmaceuticals
- Trial code
- NCT05761301
- Record updated
- 7 May 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.