A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or Obesity

NCT06568731 | Completed Phase 1 FDA Drug

• 2 other identifiers: C3421069NCT06568731
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:

• how the study medicine, danuglipron, is taken up into the blood
• about the safety and tolerability of danuglipron The total number of weeks of the study is about 15 (about 4 months).

Conditions

Obesity

Keywords

Overweight; Obesity; Danuglipron; GLP-1; Overtly healthy

Outcome Measures

Primary Outcomes (3)

• Steady-state area under the concentration-time profile from time zero to 24 hours (AUC24) for danuglipron

  Predose to 24 hours post danuglipron administration

• Steady-state maximum observed concentration (Cmax) for danuglipron

  Predose to 24 hours post danuglipron administration

• Steady-state time to reach maximum observed concentration (Tmax) for danuglipron

  Predose to 24 hours post danuglipron administration

Secondary Outcomes (5)

• Number of participants reporting Treatment Emergent Adverse Events (TEAEs)

  From baseline up to 28-35 days post last dose taken

• Number of participants reporting clinically significant clinical laboratory abnormalities

  From baseline up to 28-35 days post last dose taken

• Number of participants reporting clinically significant vital sign abnormalities

  From baseline up to 28-35 days post last dose taken

• Change from baseline in body weight

  From baseline up to 28-35 days post last dose taken

• Number of participants reporting clinically significant changes ECG abnormalities

  From baseline up to 28-35 days post last dose taken

Study Arms (1)

Single Arm

EXPERIMENTAL

Participants will receive multiple doses of danuglipron

Drug: Danuglipron

Interventions

Danuglipron DRUG

Danuglipron oral tablets

Also known as: PF-06882961

Single Arm

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight \>50 kg (110 lb)

You may not qualify if:

• Evidence or history of any clinically significant medical conditions or laboratory abnormality
• Any condition possibly affecting drug absorption
• Known intolerance/hypersensitivity to a GLP-1R agonist

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Conditions

Obesity; Overweight

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

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: August 23, 2024
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)