Recruiting
Phase 1

AMG 127

Sponsor:

Amgen

Code:

NCT07590193

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

AMG 127

Placebo

Study Details

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

Study ID

NCT07590193

Start date

Jun 11, 2026

Status verified date

Jul, 2026

Completion date

Oct 2, 2027

Anticipated

Primary completion date

Oct 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Part B: Multiple Ascending Dose (MAD)

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

experimental: Part C: Proof of Mechanism (PoM)

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

placebo comparator: Placebo

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

Interventions

AMG 127

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

Placebo

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

Primary outcome measure

  • Number of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Translational Clinical Research LLC

Recruiting

Aventura, Florida, United States, 33180

More Information

Sponsor

Amgen

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • AMG 127
  • healthy participants
  • type 2 diabetes mellitus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-03.