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 Prevention

Diabetes And Hypertension

Obesity

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

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