Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | 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
