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

In by Hannah Schaffner

Locations
Jacksonville - LaVilla (Downtown), Jacksonville - Southside, Macon
Condition
Diabetes, Overweight/Obesity

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

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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 ALN-KHK

Eligibility

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 ≥32 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
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