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

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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.

Treatment:

Drug: AMG 127

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo