Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Obesity

In brief

The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study. Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.

Key facts

Study ID

NCT05579977

Run by

Pfizer

People needed

902

Starts

2022-10-27

Expected to finish

2023-09-22

Last updated by the study team

2024-08-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• T2DM
• T2DM inadequately controlled with metformin
• BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)
• HbA1C of 7% to 10% (53-86 mmol/mol)
• FPG ≤270 mg/dL (15 mmol/L)
• Obesity
• BMI ≥30.0 kg/m2
• HbA1C ≤6.4% (47 mmol/mol)
• FPG ≤126 mg/dL (7 mmol/L)

You may not qualify if…

• Any of the following: Active/current, symptomatic gallbladder disease; History of pancreatitis in the prior 2-months;History of Type 1 Diabetes Mellitus, or secondary forms of diabetes; Any condition affecting drug absorption; Medical history of active liver disease (other than non-alcoholic hepatic steatosis)
• Use of pharmacological agents with approved indication for weight loss
• T2DM:Use of any agent (other than metformin)for the explicit purpose of glycemic control;History of diabetic ketoacidosis;Proliferative retinopathy or maculopathy requiring acute treatment;
• Obesity: Previous or planned weight reduction surgery; Major depressive disorder or other severe psychiatric disorders; Any lifetime history of a suicide attempt; PHQ-9 score ≥15; Response of "yes" to Question 4 or 5, or on any suicidal behavioral question on the C-SSRS
• Clinically significant cardiovascular conditions
• Uncontrolled blood pressure
• Personal or within first-degree relative family history of MTC or MEN2
• Other medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
• Any of the following central lab results: Fasting C-peptide <0.8 ng/mL; ALT or AST ≥2.5x ULN; Direct bilirubin >ULN or T Bili >1.5x ULN except when participants have a history of Gilbert syndrome ; TSH >1.5x ULN or <LLN; Serum calcitonin >ULN; Serum amylase or serum lipase >ULN; eGFR <45 ml/min/1.73 ; Active Hepatitis B, or Hepatitis C; A positive urine drug test for illicit drugs

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• San Fernando Valley Health Institute — Canoga Park, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Empire Clinical Research — Pomona, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Innovative Research of West Florida — Clearwater, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Adult Medicine of Lake County — Mt. Dora, Florida, United States
• Endocrine Research Solutions, Inc. — Roswell, Georgia, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• Evanston Premier Healthcare Research LLC — Skokie, Illinois, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Anderson Medical Research — Ft. Washington, Maryland, United States
• StudyMetrix Research — City of Saint Peters, Missouri, United States
• Mercury Street Medical Group, PLLC — Butte, Montana, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Premier Research — Trenton, New Jersey, United States
• Medication Management — Greensboro, North Carolina, United States
• Meridian Clinical Research, LLC — Cincinnati, Ohio, United States
• Alliance for Multispecialty Research, LLC — Norman, Oklahoma, United States
• Heritage Valley Multispecialty Group, Inc — Beaver, Pennsylvania, United States
• Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) — Pittsburgh, Pennsylvania, United States
• Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States
• Trinity Clinical Research — Centreville, Alabama, United States

Full record on ClinicalTrials.gov

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