Multiple Ascending Dose Study of AMG 598 in Subjects With Obesity

• Status: Completed
• Trial end date: 2019-12-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Men and women with ages between 18 and 65 years old, inclusive, at time of signing consent

• 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

• Except for obesity, otherwise healthy or medically stable per protocol

• 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

• Stable on liraglutide, depending on cohort

Exclusion Criteria:

• History or clinical evidence of diabetes

• Inadequate organ function at screening

• Currently receiving treatment in another investigational device or drug study

• Women who are pregnant/lactating/breastfeeding or who plan to become pregnant/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