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

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];