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Danuglipron for Obesity

Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to <65 years of age
Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight >50 kg (110 lb)
Must not have
Known intolerance/hypersensitivity to a GLP-1R agonist and/or known hypersensitivity or contraindication to atorvastatin (Cohort 1 participants) or rosuvastatin (Cohort 2 participants)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to understand how the medication danuglipron is absorbed into the blood, its interaction with other medications, and its safety in overweight or obese healthy adults. The study will be conducted in

Who is the study for?
This trial is for healthy adults aged 18 to less than 65 who are overweight or obese, with a BMI of ≥25.0-45.4 kg/m2 and weigh more than 110 pounds. It's not specified who can't join the trial.
What is being tested?
The study investigates how danuglipron is absorbed into the blood after multiple doses in overweight/obese individuals and if it affects how the body processes statins like Atorvastatin and Rosuvastatin over approximately 5.5 to 6 months.
What are the potential side effects?
While specific side effects aren't listed, participants will be monitored for safety and tolerability of danuglipron which suggests watching for any adverse reactions that may arise during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 64 years old.
Select...
My BMI is between 25.0 and 45.4, and I weigh more than 110 lbs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am allergic to GLP-1R agonists or certain cholesterol medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
Group II: Cohort 3Experimental Treatment2 Interventions
Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
Group III: Cohort 2Experimental Treatment2 Interventions
Participants will receive a single dose of rosuvastatin and multiple oral doses of danuglipron with and without rosuvastatin
Group IV: Cohort 1Experimental Treatment2 Interventions
Participants will receive a single dose of atorvastatin and multiple oral doses of danuglipron with and without atorvastatin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Danuglipron
2023
Completed Phase 1
~40
Atorvastatin
1998
Completed Phase 4
~10900
Rosuvastatin
2019
Completed Phase 4
~3150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,661 Previous Clinical Trials
17,877,458 Total Patients Enrolled
42 Trials studying Obesity
116,993 Patients Enrolled for Obesity
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,546 Previous Clinical Trials
14,918,623 Total Patients Enrolled
31 Trials studying Obesity
120,247 Patients Enrolled for Obesity
~50 spots leftby Apr 2025
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