Danuglipron for Obesity

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Significant medical conditions, Drug absorption issues, GLP-1R intolerance

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 11-13 weeks

23 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults who are generally healthy but have overweight or obesity issues. Participants will be involved in the study for approximately 15 weeks, which is about 4 months.

Inclusion Criteria

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

Exclusion Criteria

I have no significant medical conditions or abnormal lab results.

Known intolerance/hypersensitivity to a GLP-1R agonist

I have a condition that might affect how my body absorbs medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of danuglipron to evaluate pharmacokinetics, safety, and tolerability

11-13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

Treatment Details

Interventions

• Danuglipron

Trial Overview The study focuses on understanding how danuglipron, a medication under investigation, behaves in the bloodstream after multiple doses over several days and assessing its safety and tolerability in participants.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Participants will receive multiple doses of danuglipron

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University