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

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

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