Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study assessed the safety, pharmacokinetics and efficacy of bimagrumab when administered in overweight and obese patients with type 2 diabetes

Key facts

Study ID

NCT03005288

Run by

Novartis Pharmaceuticals

People needed

78

Starts

2017-02-01

Expected to finish

2019-05-08

Last updated by the study team

2021-01-05

Who can join

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

You may qualify if…

• Type 2 diabetes with HbA1c between 6.5% and 10% at screening with stable treatment for 3 months prior to randomization
• On one of the following anti-diabetes regimens with stable treatment for approximately 3 months prior to randomization: 1) metformin monotherapy; 2) DPP4 inhibitor agent monotherapy; 3) combination therapy of metformin and DPP4 inhibitor agent; 4) no anti-diabetes therapy.
• Body Mass Index of 28 to 40 kg/m2 at screening
• Body weight between 65 and 140 kg at screening

You may not qualify if…

• Women of child-bearing potential unless they are using highly effective methods of contraception
• Diabetes other than Type 2 such as Type 1 diabetes, surgically induced diabetes, "brittle" type 2 diabetes as per investigator judgement, history of severe hypoglycemic episodes in the year preceding screening or hypoglycemic unawareness
• History of clinically significant arrythmias, heart failure, unstable angina, myocardial infarction or stroke, coronary artery bypass graft surgery, or percutaneous coronary intervention, deep vein thrombosis/pulmonary embolism, valve disorders or defects, pulmonary hypertension within 6 months of screening or 1 year for drug-eluting stents
• Tachycardia
• Use of anti-obesity medications, nutritional supplements or over the counter products for weight loss within 3 months of screening
• Use of medications known to induce weight gain such as some anti-convulsant and psychotropic medications within 3 months of screening
• Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc) or has received anti-HCV treatments within the previous 6 months.
• Uncontrolled thyroid disease. Stable euthyroid patients on stable thyroid replacement therapy for at least 3 months of screening are allowed.
• Abnormal liver function tests such as SGOT, SGPT, alkaline phosphatase, or serum bilirubin, or abnormal lipase and/or amylase.
• Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis).
• Uncontrolled depression
• Use of skeletal muscle anabolic agents in any form for 3 months prior to screening
• Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min];

Where it is running

• Novartis Investigative Site — Anaheim, California, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami Lakes, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Baton Rouge, Louisiana, United States
• Novartis Investigative Site — Berlin, New Jersey, United States
• Novartis Investigative Site — Eatontown, New Jersey, United States
• Novartis Investigative Site — Merthyr Tydfil, Mid Glamorgan, United Kingdom

Full record on ClinicalTrials.gov

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