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

Last updated: May 5, 2025
Sponsor: Alnylam Pharmaceuticals
Overall Status: Terminated

Phase

1/2

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

ALN-KHK

Placebo

Clinical Study ID

NCT05761301
ALN-KHK-001
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Stable euthyroid status (no known changes in thyroid function; stable hormonereplacement 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

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

Study Design

Total Participants: 49
Treatment Group(s): 2
Primary Treatment: ALN-KHK
Phase: 1/2
Study Start date:
March 10, 2023
Estimated Completion Date:
April 03, 2025

Connect with a study center

  • Clinical Trial Site

    Sarnia, Ontario
    Canada

    Site Not Available

  • Clinical Trial Site

    Montréal, Quebec
    Canada

    Site Not Available

  • Clinical Trial Site

    Victoriaville, Quebec
    Canada

    Site Not Available

  • Clinical Trial Site

    Toronto,
    Canada

    Site Not Available

  • Clinical Trial Site

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Clinical Trial Site

    Gardena, California 90247
    United States

    Site Not Available

  • Clinical Trial Site

    Los Angeles, California 91402
    United States

    Site Not Available

  • Clinical Trial Site

    Vista, California 92083
    United States

    Site Not Available

  • Clinical Trial Site

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Clinical Trial Site

    Miami, Florida 33126
    United States

    Site Not Available

  • Clinical Trial Site

    Orlando, Florida 32806
    United States

    Site Not Available

  • Clinical Trial Site

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Clinical Trial Site

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • Clinical Trial Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Clinical Trial Site

    Monroe, North Carolina 28110
    United States

    Site Not Available

  • Clinical Trial Site

    Wilmington, North Carolina 28412
    United States

    Site Not Available

  • Clinical Trial Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Clinical Trial Site

    Austin, Texas 78744
    United States

    Site Not Available

  • Clinical Trial Site

    Dallas, Texas 75234
    United States

    Site Not Available

  • Clinical Trial Site

    Houston, Texas 77036
    United States

    Site Not Available

  • Clinical Trial Site

    San Antonio, Texas 78229
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.