Multiple Ascending Dose Study of AMG 598 in Subjects With Obesity

  • Interventional
  • Not Recruiting
  • NCT03757130
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years to 65 Years

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03757130

IRB#IRB19-0557

Lead SponsorAmgen

Lead PhysicianSilvana Pannain

Collaborator(s)N/A

EligibilityAll
18 Years to 65 Years
Not Recruiting