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

Amgen

Status and phase

Enrolling

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: AMG 127

Study type

Interventional

Funder types

Industry

Identifiers

NCT07590193

20250058

Details and patient eligibility

About

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).

Enrollment

162 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

162 participants in 4 patient groups, including a placebo group

Part A: Single Ascending Dose (SAD)

Experimental group

Description:

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.

Treatment:

Drug: AMG 127

Part B: Multiple Ascending Dose (MAD)

Experimental group

Description:

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

Treatment:

Drug: AMG 127

Part C: Proof of Mechanism (PoM)

Experimental group

Description:

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