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

Phase 1

Active, not recruiting

• Conditions: Obesity
• Interventions: Drug: Danuglipron

• Registration Number: NCT06568731
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Study Start: 2024-08-23
• Study First Posted: 2024-08-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• 18 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)

Key

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Danuglipron	Participants will receive multiple doses of danuglipron

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)	From baseline up to 28-35 days post last dose taken

Trial Locations

Locations (1)

Pfizer Clinical Research Unit - New Haven; 🇺🇸 New Haven, Connecticut, United States