NCT07590193 - A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus | Crick

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

162

Conditions

Diabetes Mellitus, Type 2

Interventions

AMG 127DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Orange County Research Center

Lake Forest, California, United States

RECRUITING

Translational Clinical Research LLC

Aventura, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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)

Central Contacts

Amgen Call Center

CONTACT

866-572-6436 medinfo@amgen.com