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Recruiting NCT07590193

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

Phase I Interventional Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AMG 127, Placebo.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug AMG 127
    AMG127 will be administered as either a SC injection or as an IV infusion.
  • Drug Placebo
    Placebo will be administered as either a SC injection or as an IV infusion.

Primary outcome measures

  • 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)]
Secondary outcome measures (3)
  • Maximum Concentration (Cmax) of AMG 127 [Time frame: 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 [Time frame: 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 [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)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Orange County Research Center — Lake Forest
  • Translational Clinical Research LLC — Aventura

Identifiers

NCT: NCT07590193 · 20250058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗