Multiple Ascending Dose Study of AMG 598 in Subjects With Obesity



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:3/30/2019
Start Date:November 26, 2018
End Date:December 12, 2019
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 598 in Subjects With Obesity

This is a randomized, double-blind, placebo-controlled, multiple ascending dose study in
subjects with obesity. AMG 598 will be evaluated in approximately 108 subjects to assess
safety, tolerability, pharmacokinetics and pharmacodynamic effects.


Inclusion Criteria:

- Men and women with ages between 18 and 65 years old, inclusive

- Except for obesity, otherwise healthy

- Body mass index (BMI) between greater than or equal to 30.0 kg/m2 and less than or
equal to 40.0 kg/m2 at screening

- Have a stable body weight defined as less than 5 kg self-reported change during the
previous 8 weeks prior to screening

- Other Inclusion criteria may apply

Exclusion Criteria:

- Currently receiving treatment in another investigational device or drug study

- Women of childbearing potential with a positive pregnancy test

- Women who are lactating/breastfeeding or who plan to breastfeed while on study through
5 months after receiving the last dose of investigational product

- History or evidence of a clinically significant disorder, condition or disease that
would pose a risk to subject safety or interfere with the study evaluation, procedures
or completion

- A family or personal history of medullary thyroid carcinoma or multiple endocrine
neoplasia type 2; a personal history of non-familial medullary thyroid carcinoma;
confirmed chronic pancreatitis or idiopathic acute pancreatitis, or gallbladder
disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy, for
cohorts receiving liraglutide

- History of major depressive disorder

- Other Exclusion criteria may apply
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