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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Danuglipron; Drug: Atorvastatin; Drug: Rosuvastatin

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
  • Florida
    • South Miami, Florida, United States, 33143
      • Qps-Mra, Llc
    • South Miami, Florida, United States, 33143
      • Qps - Mra, Llc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin	Drug: Danuglipron; Danuglipron oral tablets; Other Names: PF-06882961; Drug: Atorvastatin; Atorvastatin oral tablets
Experimental: Cohort 2; Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin	Drug: Danuglipron; Danuglipron oral tablets; Other Names: PF-06882961; Drug: Rosuvastatin; Rosuvastatin oral tablets
Experimental: Cohort 3; Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin	Drug: Danuglipron; Danuglipron oral tablets; Other Names: PF-06882961; Drug: Atorvastatin; Atorvastatin oral tablets
Experimental: Cohort 4; Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin	Drug: Danuglipron; Danuglipron oral tablets; Other Names: PF-06882961; Drug: Rosuvastatin; Rosuvastatin oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron	Predose to 24 hours post danuglipron administration
Steady-state maximum observed concentration (Cmax) for danuglipron	Predose to 24 hours post danuglipron administration
Steady-state time to reach maximum observed concentration (Tmax) for danuglipron	Predose to 24 hours post danuglipron administration
Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin	Predose to 72 hours post atorvastatin administration
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)	Predose to 72 hours post atorvastatin administration
Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin	Predose to 96 hours post rosuvastatin administration
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)	Predose to 96 hours post rosuvastatin administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)	From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant clinical laboratory abnormalities	From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant vital sign abnormalities	From baseline up to 28-35 days post last dose taken
Change from baseline in body weight	From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant changes ECG abnormalities	From baseline up to 28-35 days post last dose taken

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Actual): March 16, 2025
• Study Completion (Actual): April 14, 2025

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; GLP-1; Overweight; Atorvastatin; Rosuvastatin; Drug-drug interaction; Danuglipron; Overtly healthy
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: C3421086; NCT06567327 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No