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

• Status: Completed
• Trial end date: 2019-05-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Blocking; Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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];