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

• Sponsor: Amgen (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04199351
• Collaborator: (none)
• Enrollment: 60
• Locations: 3
• Arms: 3
• Actual Duration (Months): 20.9
• Patients Per Site: 20
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: AMG 171; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 13, 2019
• Actual Primary Completion Date: Sep 10, 2021
• Actual Study Completion Date: Sep 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A AMG 171 or placebo, 2 SAD cohorts	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.; Drug: Placebo; AMG 171 placebo
Experimental: Part B AMG 171 or placebo, 1 MAD cohort	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.; Drug: Placebo; AMG 171 placebo
Experimental: Part C AMG 171 or placebo, 3 titration cohorts	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.; Drug: Placebo; AMG 171 placebo

Outcome Measures

Primary Outcome Measures

1. Subject incidence of treatment-emergent adverse events. [through study completion, up to day 207]

2. Subject incidence of clinically significant changes in laboratory safety test results [through study completion, up to day 207]

3. Subject incidence of clinically significant changes in vital sign assessments [through study completion, up to day 207]

4. Subject incidence of clinically significant changes in 12-lead electrocardiogram (ECG) assessments [through study completion, up to day 207]

Secondary Outcome Measures

1. Pharmacokinetic parameter - maximum plasma concentration (Cmax) [through study completion, up to day 207]

2. Pharmacokinetic parameter - time to maximum plasma concentration (Tmax) [through study completion, up to day 207]

3. Pharmacokinetic parameter - area under the plasma concentration-time curve (AUC) [through study completion, up to day 207]

4. Incidence of anti-AMG 171 antibody formation [through study completion, up to day 207]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials	Anaheim	California	United States	92801
2	Orange County Research Center	Tustin	California	United States	92780
3	Clinical Pharmacology of Miami, LLC	Miami	Florida	United States	33014

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

None provided.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT04199351
• Other Study ID Numbers: 20180224
• First Posted: Dec 13, 2019
• Last Update Posted: Feb 11, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amgen: Obesity
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Feb 11, 2022