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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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06910839
Enrollment
21
Registered
2025-04-04
Start date
2025-03-13
Completion date
2025-05-20
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

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).

Interventions

PF-07976016 oral tablets

PF-06882961 oral tablets

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Fixed Sequence

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Steady state area under the concentration-time profile for PF-07976016From 0 Hours to 24 Hours following steady-state dose
Steady state maximum observed concentration (Cmax) for PF-07976016From 0 Hours to 24 Hours following steady-state dose
Steady state area under the concentration-time profile danuglipronFrom 0 Hours to 24 Hours following steady-state dose
Steady state maximum observed concentration (Cmax) for danuglipronFrom 0 Hours to 24 Hours following steady-state dose

Secondary

MeasureTime frame
Number of participants with treatment emergent adverse eventsFirst dose (Day 1) through 28-35 days after final dose (approximately 18 weeks)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026