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

Pfizer82 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (3)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Qps - Mra, Llc.

South Miami, Florida, United States

Qps-Mra, Llc

South Miami, Florida, United States

Outcomes

Primary Outcomes

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

Steady-state maximum observed concentration (Cmax) for danuglipron

Time frame: Predose to 24 hours post danuglipron administration

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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: Predose to 96 hours post rosuvastatin administration