162 Participants NeededMy employer runs this trial

AMG 127 for Type 2 Diabetes

Recruiting at 1 trial location
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Amgen

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and tolerability of a new treatment, AMG 127, for people with type 2 diabetes (T2DM). It includes multiple parts, testing both single and multiple doses of AMG 127 and comparing them to a placebo. Individuals with type 2 diabetes, aged 40 to 75, might be suitable candidates, particularly if the condition impacts daily life. Participants in Parts A and B must be healthy individuals without a diabetes diagnosis. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that AMG 127 is likely to be safe for humans?

Earlier studies primarily tested AMG 127 for safety and tolerability. Now, researchers are testing it for the first time in people with Type 2 Diabetes, so limited information exists about its safety in this population. However, earlier research has not identified any new safety concerns, suggesting that AMG 127 might be safe to use. More information is needed to confirm this. As a Phase 1 trial, the primary goal is to ensure safety, and researchers will closely monitor any side effects.12345

Why do researchers think this study treatment might be promising for type 2 diabetes?

Unlike standard treatments for type 2 diabetes, which often include oral medications like metformin or injectable insulin, AMG 127 introduces a novel approach by being administered through subcutaneous injections and potentially as an intravenous infusion. Researchers are excited about AMG 127 because it represents a new class of treatment with a unique mechanism of action that could offer more targeted control of blood sugar levels. This method has the potential to improve patient convenience and outcomes by reducing the frequency of dosing and possibly providing more stable blood glucose management.

What evidence suggests that AMG 127 might be an effective treatment for type 2 diabetes?

Research has shown that AMG 127 is under exploration as a potential treatment for type 2 diabetes. In this trial, participants will receive AMG 127 in various dosing regimens, including single ascending doses, multiple ascending doses, and multiple doses for proof of mechanism. Although limited information exists on AMG 127, it aims to control blood sugar levels and improve related health measures. Similar treatments have shown promise in aiding weight loss and managing blood sugar, both crucial for managing type 2 diabetes. AMG 127 remains in the early testing stages, so further information is needed to confirm its efficacy. The primary goal is to assess its effectiveness in managing diabetes symptoms and enhancing overall health.12678

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who are healthy, and adults aged 40-75 with confirmed type 2 diabetes. Participants must meet age and health requirements specific to each group.

Inclusion Criteria

I am between 18 and 65 years old.
Part A and B: Participant must be overtly healthy
I am between 40 and 75 years old.
See 1 more

Exclusion Criteria

I have a history of low blood pressure or fainting.
Part A and B: Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg
Part C: Hemoglobin A1c (HbA1c) >10% within the last 3 months
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of AMG 127 via subcutaneous injection, with one cohort receiving a single dose as an intravenous infusion

4-6 weeks

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of AMG 127 via subcutaneous injection

8-12 weeks

Proof of Mechanism (PoM)

Participants receive multiple doses of AMG 127 via subcutaneous injection to assess the proof of mechanism

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AMG 127

Trial Overview

The study is testing the safety of a new drug called AMG 127 by giving it as single or multiple doses. Some participants will receive AMG 127, while others get a placebo (inactive treatment) for comparison.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C: Proof of Mechanism (PoM)Experimental Treatment1 Intervention
Group II: Part B: Multiple Ascending Dose (MAD)Experimental Treatment1 Intervention
Group III: Part A: Single Ascending Dose (SAD)Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

A Trial Evaluating AMG 127 in Healthy Participants and ...

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 ...

RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ...

In the Phase 2 study, MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D) compared ...

A Trial Evaluating AMG 127 in Healthy Participants and ...

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

RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY ...

MariTide demonstrated up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D) compared with 2.6% in the ...

A real‐world study of treatment patterns and outcomes in US ...

During 12‐months of follow‐up, treatment persistence was 64%, mean HbA1c reduction was −1.24% and weight change was + 1.17 among GLA patients, and was 49%, −0. ...

Amgen's AMG 127 Trial Signals a New Push Into Type 2 ...

Positive safety and early response data from AMG 127 could support a stronger long-term pipeline story and help sentiment around AMGN, ...

AMG 127 Ph 1 for Diabetes Mellitus, Type 2

AMG 127 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of Type 2 Diabetes ...

A Trial Evaluating AMG 127 in Healthy Participants and ...

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 ...