AMG 127 for Type 2 Diabetes
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Multiple Ascending Dose (MAD)
Participants receive multiple ascending doses of AMG 127 via subcutaneous injection
Proof of Mechanism (PoM)
Participants receive multiple doses of AMG 127 via subcutaneous injection to assess the proof of mechanism
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will receive multiple doses of AMG 127 via SC injection.
Participants will receive multiple ascending doses of AMG 127 via SC injection.
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.
Participants will receive a matching placebo as either a SC injection or as an IV infusion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
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 ...
3.
ctv.veeva.com
ctv.veeva.com/study/a-trial-evaluating-amg-127-in-healthy-participants-and-participants-with-type-2-diabetes-mellitusA 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. ...
6.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AMGN/pressreleases/3641488/amgens-amg-127-trial-signals-a-new-push-into-type-2-diabetes/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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.