Clinical trial NCT03757130: Multiple Ascending Dose Study of AMG 598 in Adults With Obesity
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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 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/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 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: 207 days
measure: Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
timeFrame: 207 days
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
timeFrame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
measure: Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
timeFrame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
measure: Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
timeFrame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
measure: Area Under the Concentration-time Curve From Time 0 to 28 Days (AUC0-28) for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
timeFrame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
measure: Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
timeFrame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
measure: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of AMG 598 After Subcutaneous Injection on Day 57
timeFrame: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
measure: Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
timeFrame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
measure: Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
timeFrame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
measure: Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57
timeFrame: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: William D Summers MD LLC
state: Alabama
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: South Miami
country: United States
facility: QPS Miami Research Associates
state: Florida
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: