A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: AMG 127; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Part A and B

• Participant must be 18-65 years of age
• Participant must be overtly healthy

Inclusion Criteria for Part C

• Participant must be 40-75 years of age
• Confirmed diagnoses of T2DM

Exclusion Criteria for Part A and B

• History of hypotension, syncope, or orthostatic intolerance
• Systolic blood pressure >140 millimeters of mercury (mmHg) or diastolic blood pressure >90 mmHg

Exclusion Criteria for Part C

• Hemoglobin A1c (HbA1c) >10% within the last 3 months
• History of hypotension, syncope, or orthostatic intolerance
• Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Single Ascending Dose (SAD); Participants will receive single ascending doses of AMG 127 via subcutaneous (SC) injection. One cohort will receive a single dose of AMG 127 as an intravenous (IV) infusion.	Drug: AMG 127; AMG127 will be administered as either a SC injection or as an IV infusion.
Experimental: Part B: Multiple Ascending Dose (MAD); Participants will receive multiple ascending doses of AMG 127 via SC injection.	Drug: AMG 127; AMG127 will be administered as either a SC injection or as an IV infusion.
Experimental: Part C: Proof of Mechanism (PoM); Participants will receive multiple doses of AMG 127 via SC injection.	Drug: AMG 127; AMG127 will be administered as either a SC injection or as an IV infusion.
Placebo Comparator: Placebo; Participants will receive a matching placebo as either a SC injection or as an IV infusion.	Drug: Placebo; Placebo will be administered as either a SC injection or as an IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Treatment-Emergent Adverse Events (TEAEs)	Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)
Number of Serious Adverse Events (SAEs)	Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days)
Number of Adverse Events Leading to Study Discontinuation	Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Concentration (Cmax) of AMG 127	Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)
Area Under the Curve (AUC) of AMG 127	Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)
Incidence and Severity of Retinal Structural Abnormalities Assessed by Optical Coherence Tomography (OCT) in Participants With Type 2 Diabetes Mellitus	Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 2, 2027
• Study Completion (Estimated): October 2, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; healthy participants; AMG 127
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20250058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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 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 data sharing request for this study.
• IPD Sharing 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No