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

NCT04199351 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 20180224
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. A serious AE (SAE) was an AE meeting at least 1 of the following serious criteria: fatal, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability; congenital anomaly/birth defect; other medically important serious event. Clinically significant changes from baseline in laboratory safety tests, vital sign assessments, and 12-lead electrocardiogram assessments were included as TEAEs.

  From first dose of IP to end of study, up to Day 207

Secondary Outcomes (8)

• Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b

  Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120

• Cmax for AMG 171: MAD Cohorts 2 - 5

  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

• Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b

  Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120

• Tmax for AMG 171: MAD Cohorts 2 - 5

  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

• Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b

  Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120

Study Arms (3)

Part A

EXPERIMENTAL

AMG 171 or placebo, 2 SAD cohorts

Drug: AMG 171; Drug: Placebo

Part B

EXPERIMENTAL

AMG 171 or placebo, 1 MAD cohort

Drug: AMG 171; Drug: Placebo

Part C

EXPERIMENTAL

AMG 171 or placebo, 3 titration cohorts

Drug: AMG 171; Drug: Placebo

Interventions

AMG 171 DRUG

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.

Part A; Part B; Part C

Placebo DRUG

AMG 171 placebo

Part A; Part B; Part C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: December 13, 2019
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (3)