Clinical trial NCT04199351: Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 171 in Subjects With Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 60
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: TREATMENT

Brief summary: To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity


Eligibility criteria: Inclusion Criteria

* Males and females with ages between 18 and 65 years old, inclusive
* Except for obesity, otherwise healthy
* Body mass index (BMI) greater than or equal to 30.0 kg/m2 and less than or equal to 40.0 kg/m2 at screening
* Other Inclusion criteria may apply

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study
* Women of childbearing potential
* 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
* Other Exclusion criteria may apply

Primary outcomes:
measure: Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of IP to end of study, up to Day 207
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b
timeFrame: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
measure: Cmax for AMG 171: MAD Cohorts 2 - 5
timeFrame: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
measure: Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b
timeFrame: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
measure: Tmax for AMG 171: MAD Cohorts 2 - 5
timeFrame: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
measure: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b
timeFrame: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
measure: AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4
timeFrame: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113
measure: AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5
timeFrame: Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
measure: Number of Participants With Anti-AMG 171 Antibodies
timeFrame: Cohorts 1 and 1b: Day 1 pre-dose, Days 15, 29, 120; Cohort 2: Days 1, 29, 57 pre-dose, Days 15, 85, 207; Cohort 3: Days 1, 15 pre-dose, Days 29, 57, 85; Cohort 4: Days 1, 15, 29 pre-dose, Days 43, 85, 113; Cohort 5: Days 1, 8 pre-dose, Days 29, 57, 85
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: