Study to Learn About How the Study Medicines Called PF-07976016 and PF-06882961 Are Taken Up by the Body, and if Either of Them Change How the Body Processes the Other Medicine in Otherwise Healthy Adults With Overweight or Obesity

A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE PHARMACOKINETIC INTERACTIONS BETWEEN PF-07976016 AND PF-06882961 IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY

The purpose of this study is to see how two study medicines, PF-07976016 and danuglipron, taken together affect the level of each other in the blood of participants who have overweight or obesity.

The total number of weeks of the study is up to approximately 22 weeks (5.5 months).

Study Overview

• Status: Terminated
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: PF-07976016; Drug: PF-06882961

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and non-pregnant, non-breastfeeding female, 18 to 65 years of age
• BMI 25 to 40 kg/m2 and a total body weight > 50 kg (110 lb)
• Willing and able to comply with all study procedures including staying a research unit for up to 95 days

Exclusion Criteria:

• Any medical or psychiatric condition or laboratory abnormality, or recent serious illness or hospitalization, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study including diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes
• Use of any prohibited prior or concomitant medication(s)
• Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests
• A positive urine drug test.
• History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence
• Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1; Participants will receive doses of PF-07976016 with and without PF-06882961	Drug: PF-07976016; PF-07976016 oral tablets; Drug: PF-06882961; PF-06882961 oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Steady state area under the concentration-time profile for PF-07976016	From 0 Hours to 24 Hours following steady-state dose
Steady state maximum observed concentration (Cmax) for PF-07976016	From 0 Hours to 24 Hours following steady-state dose
Steady state area under the concentration-time profile danuglipron	From 0 Hours to 24 Hours following steady-state dose
Steady state maximum observed concentration (Cmax) for danuglipron	From 0 Hours to 24 Hours following steady-state dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment emergent adverse events	First dose (Day 1) through 28-35 days after final dose (approximately 18 weeks)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 20, 2025

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: C5541009

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
• product manufactured in and exported from the U.S.: No