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

Phase 1

Active, not recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: PF-07976016; Drug: PF-06882961

• Registration Number: NCT06910839
• Lead Sponsor: Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-12
• Study Start: 2025-03-13
• Study First Submitted QC: 2025-03-27
• Status Verified: 2025-04
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-05-20
• Study Completion: 2025-05-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Period 1	PF-07976016	Participants will receive doses of PF-07976016 with and without PF-06882961
Period 1	PF-06882961	Participants will receive doses of PF-07976016 with and without PF-06882961

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States