A Study to Learn How the Study Medicine Danuglipron is Taken Up Into the Blood and If Danuglipron Changes How the Body Processes Other Study Medicines (Atorvastatin and Rosuvastatin) in Healthy Adults Who Are Overweight or Obese

Last updated: March 27, 2025
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

1

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

Rosuvastatin

Danuglipron

Atorvastatin

Clinical Study ID

NCT06567327
C3421086
  • Ages 18-64
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:

  • how the study medicine, danuglipron, is taken up into the blood

  • if the study medicine, danuglipron, changes how the body processes other study medicines (Atorvastatin and Rosuvastatin)

  • about the safety and tolerability of danuglipron

The study will take place in 4 Cohorts (groups). The total number of weeks of the study is about 23 (about 6 months) for Cohort 1 and 22 weeks (about 5.5 months) for Cohort 2, 21 weeks (about 5 months) for Cohort 3 and 20 weeks (about 5 months) for Cohort 4.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • 18 to < 65 years of age

  • Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion

Key Exclusion Criteria:

  • Evidence or history of any clinically significant medical conditions or laboratoryabnormality

  • Any condition possibly affecting drug absorption

  • Known intolerance/hypersensitivity to a GLP-1R agonist and/or known hypersensitivityor contraindication to atorvastatin (Cohort 1 and 3 participants) or rosuvastatin (Cohort 2 and 4 participants)

Study Design

Total Participants: 82
Treatment Group(s): 3
Primary Treatment: Rosuvastatin
Phase: 1
Study Start date:
August 28, 2024
Estimated Completion Date:
April 19, 2025

Connect with a study center

  • Anaheim Clinical Trials, LLC

    Anaheim, California 92801
    United States

    Site Not Available

  • Qps - Mra, Llc.

    South Miami, Florida 33143
    United States

    Site Not Available

  • Qps-Mra, Llc

    South Miami, Florida 33143
    United States

    Site Not Available

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