C3991004 -T2DM

  • STATUS
    Recruiting
  • participants needed
    780
Updated on 30 January 2023

Summary

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.

Description


Details
Condition Type 2 diabetes
Clinical Study IdentifierTX307745
Last Modified on30 January 2023

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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