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

NCT05761301 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-05-07

No results posted yet for this study

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

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

ALN-KHK

ALN-KHK will be administered by subcutaneous (SC) injection.

DRUG

Placebo

Placebo will be administered by subcutaneous (SC) injection.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-10
Primary Completion
2025-04-03
Completion
2025-04-03
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761301 on ClinicalTrials.gov