NCT06567327CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 9 Aug 2024
- Start date
- 28 Aug 2024
- Primary completion date
- 16 Mar 2025
- Lead sponsor
- Pfizer
- Diseases
- Obesity
- NCT number
- NCT06567327
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 82
- From 28 Aug 2024 to the primary completion date, 16 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- Evidence or history of any clinically significant medical conditions or laboratory abnormality
Who the study is looking for
- 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)
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anaheim Clinical Trials, LLC Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Qps-Mra, Llc Coordinator of this site? Confirm its status | South Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.