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

NCT06910839 | Terminated Phase 1 FDA Drug

• 1 other identifier: C5541009
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Number of participants with treatment emergent adverse events

  First dose (Day 1) through 28-35 days after final dose (approximately 18 weeks)

Study Arms (1)

Period 1

EXPERIMENTAL

Participants will receive doses of PF-07976016 with and without PF-06882961

Drug: PF-07976016; Drug: PF-06882961

Interventions

PF-07976016 DRUG

PF-07976016 oral tablets

Period 1

PF-06882961 DRUG

PF-06882961 oral tablets

Period 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Related Links

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

MeSH Terms

Conditions

Overweight; Obesity

Interventions

danuglipron

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fixed Sequence

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 4, 2025
• Study Start: March 13, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 20, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)