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

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 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 ≥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:

• 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