A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or Obesity

January 16, 2025 updated by: Pfizer

A PHASE 1, OPEN- LABEL STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY

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
  • about the safety and tolerability of danuglipron

The total number of weeks of the study is about 15 (about 4 months).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Clinical Research Unit - New Haven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  • 18 years of age or older
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Participants will receive multiple doses of danuglipron
Drug: Danuglipron
Danuglipron oral tablets
Other Names:
  • PF-06882961

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Predose to 24 hours post danuglipron administration
Steady-state maximum observed concentration (Cmax) for danuglipron
Time Frame: Predose to 24 hours post danuglipron administration
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
Predose to 24 hours post danuglipron administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)
Time Frame: From baseline up to 28-35 days post last dose taken
From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant clinical laboratory abnormalities
Time Frame: From baseline up to 28-35 days post last dose taken
From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant vital sign abnormalities
Time Frame: From baseline up to 28-35 days post last dose taken
From baseline up to 28-35 days post last dose taken
Change from baseline in body weight
Time Frame: From baseline up to 28-35 days post last dose taken
From baseline up to 28-35 days post last dose taken
Number of participants reporting clinically significant changes ECG abnormalities
Time Frame: From baseline up to 28-35 days post last dose taken
From baseline up to 28-35 days post last dose taken

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2024

Primary Completion (Actual)

December 18, 2024

Study Completion (Actual)

December 18, 2024

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3421069
  • NCT06568731 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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