Clinical trial NCT06910839: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Overweight
Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-04-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Fixed Sequence
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Steady state area under the concentration-time profile for PF-07976016
timeFrame: From 0 Hours to 24 Hours following steady-state dose
measure: Steady state maximum observed concentration (Cmax) for PF-07976016
timeFrame: From 0 Hours to 24 Hours following steady-state dose
measure: Steady state area under the concentration-time profile danuglipron
timeFrame: From 0 Hours to 24 Hours following steady-state dose
measure: Steady state maximum observed concentration (Cmax) for danuglipron
timeFrame: From 0 Hours to 24 Hours following steady-state dose
Secondary outcomes:
measure: Number of participants with treatment emergent adverse events
timeFrame: First dose (Day 1) through 28-35 days after final dose (approximately 18 weeks)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: