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New treatment option for Diabetes Mellitus
Official title AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
ClinicalTrials.gov ID: NCT07533175
What this study is testing
What is NNC0487-0111?
NNC0487-0111 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female (sex at birth).
- Age 18 years or above at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus more than equal to (≥) 180 days before screening.
- Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides...
- Haemoglobin A1c (HbA1c) 7-10% [53-86 (millimoles per mole) mmol/mol] (both inclusive) as measured by the central laboratory at screening.
You likely can't join if
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter per minute per meter square (mL/min/1.73 m\^2) [2021...
- Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial...
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
- Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Escondido, California, United States
- Lomita, California, United States
- Walnut Creek, California, United States
- Fleming Island, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Oviedo, Florida, United States
- Minneapolis, Minnesota, United States
- West Seneca, New York, United States
- Spartanburg, South Carolina, United States
- Chattanooga, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Richmond, Virginia, United States
- Manuel Alberti, Buenos Aires, Argentina
- Buenos Aires, Argentina
- Córdoba, Argentina
- Santa Fe, Argentina
- Curitiba, Paraná, Brazil
+ 42 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Escondido, California, United States; Lomita, California, United States; Walnut Creek, California, United States; Fleming Island, Florida, United States; Jacksonville, Florida, United States and 56 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.