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OpenTrials
Completed

NCT Number: NCT06568731

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danuglipron

Drug

Danuglipron oral tablets

Other names: PF-06882961

Primary outcomes

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

    Time frame: Predose to 24 hours post danuglipron administration

  2. Steady-state maximum observed concentration (Cmax) for danuglipron

    Time frame: Predose to 24 hours post danuglipron administration

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

    Time frame: Predose to 24 hours post danuglipron administration

Secondary outcomes

  1. Number of participants reporting Treatment Emergent Adverse Events (TEAEs)

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

  2. Number of participants reporting clinically significant clinical laboratory abnormalities

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

  3. Number of participants reporting clinically significant vital sign abnormalities

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

  4. Change from baseline in body weight

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

  5. Number of participants reporting clinically significant changes ECG abnormalities

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, OPEN- LABEL STUDY TO EVALUATE THE MULTIPLE DOSE PHARMACOKINETICS OF DANUGLIPRON FOLLOWING ORAL ADMINISTRATION IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OVERWEIGHT OR OBESITY

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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