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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Danuglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT06568731

C3421069

NCT06568731 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Single Arm

Experimental group

Description:

Participants will receive multiple doses of danuglipron

Treatment:

Drug: Danuglipron