C3991004 - Obesity

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Updated on 27 February 2023
diabetes
metformin
sugars

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

Inclusion Criteria:
T2DM
  1. T2DM inadequately controlled with metformin
  2. BMI ≥23.0 kg/m2 (≥20.0 kg/m2 in Japan)
  3. HbA1C of 7% to 10% (53-86 mmol/mol)
  4. FPG ≤270 mg/dL (15 mmol/L) Obesity
  5. BMI ≥30.0 kg/m2
  6. HbA1C ≤6.4% (47 mmol/mol)
  7. FPG ≤126 mg/dL (7 mmol/L)
Exclusion Criteria:
  1. 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)
  2. Use of pharmacological agents with approved indication for weight loss
  3. 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;
  4. 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
  5. Clinically significant cardiovascular conditions
  6. Uncontrolled blood pressure
  7. Personal or within first-degree relative family history of MTC or MEN2
  8. 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
  9. 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

Details
Condition Obesity
Clinical Study IdentifierTX310275
Last Modified on27 February 2023

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