Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Overweight
Obesity
Danuglipron
GLP-1
Drug-drug interaction
Overtly healthy
Atorvastatin
Rosuvastatin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron
timeFrame: Predose to 24 hours post danuglipron administration
measure: Steady-state maximum observed concentration (Cmax) for danuglipron
timeFrame: Predose to 24 hours post danuglipron administration
measure: Steady-state time to reach maximum observed concentration (Tmax) for danuglipron
timeFrame: Predose to 24 hours post danuglipron administration
measure: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for atorvastatin
timeFrame: Predose to 72 hours post atorvastatin administration
measure: 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)
timeFrame: Predose to 72 hours post atorvastatin administration
measure: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for rosuvastatin
timeFrame: Predose to 96 hours post rosuvastatin administration
measure: 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)
timeFrame: Predose to 96 hours post rosuvastatin administration
Secondary outcomes:
measure: Number of participants reporting Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline up to 28-35 days post last dose taken
measure: Number of participants reporting clinically significant clinical laboratory abnormalities
timeFrame: From baseline up to 28-35 days post last dose taken
measure: Number of participants reporting clinically significant vital sign abnormalities
timeFrame: From baseline up to 28-35 days post last dose taken
measure: Change from baseline in body weight
timeFrame: From baseline up to 28-35 days post last dose taken
measure: Number of participants reporting clinically significant changes ECG abnormalities
timeFrame: From baseline up to 28-35 days post last dose taken
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: South Miami
country: United States
facility: Qps - Mra, Llc.
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: