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

NCT06567327 | Completed Phase 1 FDA Drug

• 2 other identifiers: C3421086NCT06567327
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Obesity

Keywords

Overweight; Obesity; Danuglipron; GLP-1; Drug-drug interaction; Overtly healthy; Atorvastatin; Rosuvastatin

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• 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

Study Arms (4)

Cohort 1

EXPERIMENTAL

Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin

Drug: Danuglipron; Drug: Atorvastatin

Cohort 2

EXPERIMENTAL

Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin

Drug: Danuglipron; Drug: Rosuvastatin

Cohort 3

EXPERIMENTAL

Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin

Drug: Danuglipron; Drug: Atorvastatin

Cohort 4

EXPERIMENTAL

Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin

Drug: Danuglipron; Drug: Rosuvastatin

Interventions

Danuglipron DRUG

Danuglipron oral tablets

Also known as: PF-06882961

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Atorvastatin DRUG

Atorvastatin oral tablets

Cohort 1; Cohort 3

Rosuvastatin DRUG

Rosuvastatin oral tablets

Cohort 2; Cohort 4

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Qps - Mra, Llc.

South Miami, Florida, 33143, United States

Location

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Related Links

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

MeSH Terms

Conditions

Obesity; Overweight

Interventions

danuglipron; Atorvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 22, 2024
• Study Start: August 28, 2024
• Primary Completion: March 16, 2025
• Study Completion: April 14, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)