Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04199351
• Other study ID #: 20180224
• Status: Terminated
• Phase: Phase 1
• Start date: December 13, 2019
• Est. completion date: September 10, 2021

Study information

• Verified date: September 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: September 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• AMG 171
2 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A; 1 cohort of 8 subjects 3:1 ratio in Part B; and 24 subjects enrolled into 1 of 3 cohorts with 8 subjects randomized to receive 2 to 3 consecutive doses (titration) 3:1 ratio in Part C.
• Placebo
AMG 171 placebo

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of treatment-emergent adverse events.		through study completion, up to day 207
Primary	Subject incidence of clinically significant changes in laboratory safety test results		through study completion, up to day 207
Primary	Subject incidence of clinically significant changes in vital sign assessments		through study completion, up to day 207
Primary	Subject incidence of clinically significant changes in 12-lead electrocardiogram (ECG) assessments		through study completion, up to day 207
Secondary	Pharmacokinetic parameter - maximum plasma concentration (Cmax)		through study completion, up to day 207
Secondary	Pharmacokinetic parameter - time to maximum plasma concentration (Tmax)		through study completion, up to day 207
Secondary	Pharmacokinetic parameter - area under the plasma concentration-time curve (AUC)		through study completion, up to day 207
Secondary	Incidence of anti-AMG 171 antibody formation		through study completion, up to day 207

External Links

•   AmgenTrials clinical trials website