Status:
COMPLETED
Multiple Ascending Dose Study of AMG 598 in Adults With Obesity
Lead Sponsor:
Amgen
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The main objective of this study is to assess the safety and tolerability of multiple doses of AMG 598 administered alone or in combination with liraglutide in adults with obesity.
Eligibility Criteria
Inclusion
- 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/m\^2 and less than or equal to 40.0 kg/m\^2 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
- 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
Key Trial Info
Start Date :
November 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03757130
Start Date
November 26 2018
End Date
December 16 2019
Last Update
September 14 2023
Active Locations (4)
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1
William D Summers MD LLC
Birmingham, Alabama, United States, 35235
2
Orange County Research Center
Tustin, California, United States, 92780
3
QPS Miami Research Associates
South Miami, Florida, United States, 33143
4
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States, 75230