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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04199351
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 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 : December 13, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Arm Intervention/treatment
Experimental: Part A
AMG 171 or placebo, 7 SAD cohorts
Drug: AMG 171
7 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A, 4 MAD cohorts of 8 subjects per cohort randomized 3:1 in Part B and 1 expansion cohort in Part C

Drug: Placebo
7 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A, 4 MAD cohorts of 8 subjects per cohort randomized 3:1 in Part B and 1 expansion cohort in Part C

Experimental: Part B
AMG 171 or placebo, 4 MAD cohorts
Drug: AMG 171
7 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A, 4 MAD cohorts of 8 subjects per cohort randomized 3:1 in Part B and 1 expansion cohort in Part C

Drug: Placebo
7 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A, 4 MAD cohorts of 8 subjects per cohort randomized 3:1 in Part B and 1 expansion cohort in Part C

Experimental: Part C
AMG 171 or placebo, 1 cohort
Drug: AMG 171
7 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A, 4 MAD cohorts of 8 subjects per cohort randomized 3:1 in Part B and 1 expansion cohort in Part C

Drug: Placebo
7 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A, 4 MAD cohorts of 8 subjects per cohort randomized 3:1 in Part B and 1 expansion cohort in Part C




Primary Outcome Measures :
  1. Subject incidence of treatment-emergent adverse events. [ Time Frame: through study completion, up to day 207 ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameter - maximum plasma concentration (Cmax) [ Time Frame: through study completion, up to day 207 ]
  2. Pharmacokinetic parameter - time to maximum plasma concentration (Tmax) [ Time Frame: through study completion, up to day 207 ]
  3. Pharmacokinetic parameter - area under the plasma concentration-time curve (AUC) [ Time Frame: through study completion, up to day 207 ]
  4. Incidence of anti-AMG 171 antibody formation [ Time Frame: through study completion, up to day 207 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04199351


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
Research Site Recruiting
Anaheim, California, United States, 92801
Research Site Recruiting
Tustin, California, United States, 92780
United States, Florida
Research Site Recruiting
Miami, Florida, United States, 33014
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04199351    
Other Study ID Numbers: 20180224
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a datasharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

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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:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight