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.
18 Years to 65 Years
Accepting Healthy Volunteers?
- 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
- 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