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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07590193

Enrollment

162

Registered

2026-05-15

Start date

2026-06-11

Completion date

2027-10-02

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

AMG 127, healthy participants, type 2 diabetes mellitus

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).

Interventions

DRUGAMG 127

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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)
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)

Countries

United States

Contacts

CONTACTAmgen Call Center

medinfo@amgen.com866-572-6436

STUDY_DIRECTORMD

Amgen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026