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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Rosuvastatin; Drug: Atorvastatin; Drug: Danuglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06567327

NCT06567327 (Registry Identifier)

C3421086

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 4 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Danuglipron

Drug: Atorvastatin

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Danuglipron

Drug: Rosuvastatin

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: Danuglipron

Drug: Atorvastatin

Cohort 4

Experimental group

Description:

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

Treatment:

Drug: Danuglipron

Drug: Rosuvastatin