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OpenTrials
Completed

NCT Number: NCT06567327

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Key Exclusion Criteria:

  • Evidence or history of any clinically significant medical conditions or laboratory abnormality
  • Any condition possibly affecting drug absorption
  • Known intolerance/hypersensitivity to a GLP-1R agonist and/or known hypersensitivity or contraindication to atorvastatin (Cohort 1 and 3 participants) or rosuvastatin (Cohort 2 and 4 participants)

Treatment and study plan

Danuglipron

Drug

Danuglipron oral tablets

Other names: PF-06882961

atorvastatin

Drug

Atorvastatin oral tablets

Rosuvastatin

Drug

Rosuvastatin oral tablets

Primary outcomes

  1. Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron

    Time frame: Predose to 24 hours post danuglipron administration

  2. Steady-state maximum observed concentration (Cmax) for danuglipron

    Time frame: Predose to 24 hours post danuglipron administration

  3. Steady-state time to reach maximum observed concentration (Tmax) for danuglipron

    Time frame: Predose to 24 hours post danuglipron administration

  4. Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin

    Time frame: Predose to 72 hours post atorvastatin administration

  5. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for atorvastatin (only if AUCinf is not reportable)

    Time frame: Predose to 72 hours post atorvastatin administration

  6. Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin

    Time frame: Predose to 96 hours post rosuvastatin administration

  7. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for rosuvastatin (only if AUCinf is not reportable)

    Time frame: Predose to 96 hours post rosuvastatin administration

Secondary outcomes

  1. Number of participants reporting Treatment Emergent Adverse Events (TEAEs)

    Time frame: From baseline up to 28-35 days post last dose taken

  2. Number of participants reporting clinically significant clinical laboratory abnormalities

    Time frame: From baseline up to 28-35 days post last dose taken

  3. Number of participants reporting clinically significant vital sign abnormalities

    Time frame: From baseline up to 28-35 days post last dose taken

  4. Change from baseline in body weight

    Time frame: From baseline up to 28-35 days post last dose taken

  5. Number of participants reporting clinically significant changes ECG abnormalities

    Time frame: From baseline up to 28-35 days post last dose taken

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Two-Part Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Multiple Dose Pharmacokinetics of Danuglipron Following Oral Administration and The Effects of Steady-State Danuglipron on the Pharmacokinetics of Single Oral Dose of Atorvastatin and Rosuvastatin in Otherwise Healthy Adult Participants With Overweight or Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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