Trials / Terminated
TerminatedNCT05761301
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)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Alnylam Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALN-KHK | ALN-KHK will be administered by subcutaneous (SC) injection. |
| DRUG | Placebo | Placebo will be administered by subcutaneous (SC) injection. |
Timeline
- Start date
- 2023-03-10
- Primary completion
- 2025-04-03
- Completion
- 2025-04-03
- First posted
- 2023-03-09
- Last updated
- 2025-05-07
Locations
15 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05761301. Inclusion in this directory is not an endorsement.