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

NCT07590193 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 20250058
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Diabetes Mellitus, Type 2

Keywords

AMG 127; healthy participants; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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)

Study Arms (4)

Part A: Single Ascending Dose (SAD)

EXPERIMENTAL

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

Part B: Multiple Ascending Dose (MAD)

EXPERIMENTAL

Participants will receive multiple ascending doses of AMG 127 via SC injection.

Drug: AMG 127

Part C: Proof of Mechanism (PoM)

EXPERIMENTAL

Participants will receive multiple doses of AMG 127 via SC injection.

Drug: AMG 127

Placebo

PLACEBO COMPARATOR

Participants will receive a matching placebo as either a SC injection or as an IV infusion.

Drug: Placebo

Interventions

AMG 127 DRUG

AMG127 will be administered as either a SC injection or as an IV infusion.

Part A: Single Ascending Dose (SAD); Part B: Multiple Ascending Dose (MAD); Part C: Proof of Mechanism (PoM)

Placebo DRUG

Placebo will be administered as either a SC injection or as an IV infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18-65 years of age
• Participant must be overtly healthy
• Participant must be 40-75 years of age
• Confirmed diagnoses of T2DM

You may not qualify if:

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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

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

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 2, 2027
• Study Completion (Estimated): October 2, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

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 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.
• 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.