Clinical Trial 51478

Pomonca, CA 91767


Summary:

Type II Diabetes - Pomonca CA (Metro Los Angeles)
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This is a multicenter, multinational, randomized, double-blind, double-dummy, placebo-controlled, dose-ranging, dose-finding, parallel-group study to access efficacy and safety/tolerability of PF-07081532, and open-label Rybelsus, in adults with T2DM inadequately controlled on metformin (Stratum 1), and separately PF-07081532 compared to matching placebo in adults with obesity but without T2DM (Stratum 2)



To be Quflied for Pfizer Type II Diatebes 

  •   Male or female 18 years or older (or the minimum age of consent in accordance with local regulations) and up to 75 years, inclusively, at the Screening Visit

  • Participants diagnosed with T2DM inadequately controlled with metformin at doses ≥500 mg/day (and up to the highest approved in-country dose) with metformin dose stable for ≥8 weeks prior to Screening Visit.

  • BMI ≥23.0 kg/m2

Exculsion: 

  • Use of any pharmacological agent with an approved indication for T2DM (other than metformin), or herbal medications, for the explicit purpose of glycemic control within 12 weeks of the Screening Visit.

  • Medical Conditions: 1. Any of the following clinically significant medical conditions –

    ·         Active/current, symptomatic gallbladder disease.

    ·          History of pancreatitis in the 12 months prior to the Screening Visit.

    ·         History of Type 1 Diabetes Mellitus, or secondary forms of diabetes (NOTE: a history of gestational diabetes that has resolved is allowed).

  •   Any condition affecting drug absorption (e.g., prior bariatric surgery, gastrectomy, or any area of intestinal resection, active inflammatory bowel disease, or pancreatic insufficiency);

  •  Known medical history of active liver disease (other than non-alcoholic hepatic steatosis), including active hepatitis, primary biliary cirrhosis, and ascites; 2. Use of pharmacological agents with an approved indication for weight loss (e.g., orlistat, sibutramine, GLP-1R agonists), over-the-counter appetite-stimulant or appetitesuppressant, as advertised, within 12 weeks of Screening Visit; or weight loss of >5% in the 12 weeks prior to Screening Visit, based on participants medical records or as reported by the participant.

 


Qualified Participants May Receive:

How study Particpation will be $2,000 this amount will be in breakdowns. 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.