NNC0487-0111 for Obesity and Type 2 Diabetes
(AMAZE 8 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, NNC0487-0111 (an experimental treatment), to determine its safety and effectiveness for people with obesity and type 2 diabetes. Participants will receive two injections each week: one of either NNC0487-0111 or a commonly used treatment, Semaglutide, and the other a placebo (a treatment with no active medicine). The trial aims to assess how well these treatments work when combined with a reduced-calorie diet and increased physical activity. Suitable candidates for this trial have had type 2 diabetes for at least six months and are currently managing it with lifestyle changes or up to three oral medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify that you need to stop your current medications. However, your treatment with oral antidiabetic drugs should be stable before screening, meaning you should be on the same drugs, dose, and dosing frequency.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that NNC0487-0111, a new treatment being tested for obesity and type 2 diabetes, is generally safe and well-tolerated. In earlier studies, participants taking NNC0487-0111 lost a significant amount of weight without serious side effects. Most side effects were mild, such as nausea or headache, which are common with similar treatments.
For comparison, Semaglutide, an approved medication for these conditions, is known to be safe and effective. Participants in the current study will receive either NNC0487-0111 or Semaglutide, both administered as weekly injections.
Overall, past research suggests that the safety of NNC0487-0111 looks promising. However, participants should discuss any concerns with their healthcare providers before joining a trial.12345Why do researchers think this study treatment might be promising for obesity and type 2 diabetes?
NNC0487-0111 is unique because it offers a new approach to managing obesity and type 2 diabetes by potentially working through a different mechanism of action compared to existing treatments like metformin or insulin, which primarily focus on blood sugar regulation. This treatment is administered subcutaneously once a week, which could be more convenient than daily medications. Researchers are excited about its potential to enhance the effectiveness of lifestyle changes, such as a reduced-calorie diet and increased physical activity, making it an innovative option for tackling these conditions.
What evidence suggests that this trial's treatments could be effective for obesity and type 2 diabetes?
Research shows that NNC0487-0111, also known as Amycretin, helps people with type 2 diabetes lose weight and control blood sugar levels. In earlier studies, participants lost a significant amount of weight, with some losing up to 9.7% of their body weight. The treatment also improved insulin response, which is crucial for managing diabetes. These results offer hope for people with obesity and type 2 diabetes. In this trial, participants will receive either NNC0487-0111 or semaglutide, each alongside a reduced-calorie diet and increased physical activity. NNC0487-0111 works by affecting two pathways that control hunger and satiety, aiding in weight and blood sugar management.16789
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for adults over 18 with type 2 diabetes and excess body weight. They must have been diagnosed at least 180 days prior and have specific HbA1c levels. Participants can be on up to three types of oral diabetes medications, but these should be stable before joining.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either NNC0487-0111 or Semaglutide with a placebo, administered subcutaneously once weekly, alongside a reduced-calorie diet and increased physical activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NNC0487-0111
Trial Overview
The study tests NNC0487-0111 against Semaglutide in people with obesity and type 2 diabetes. Each participant gets weekly injections: one active medicine (either NNC0487-0111 or Semaglutide) plus a placebo, assigned randomly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen
Citations
NCT07400107 | AMAZE 8: A Research Study Investigating ...
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 ...
2.
pharmacytimes.com
pharmacytimes.com/view/amycretin-shows-significant-weight-loss-hba1c-reductions-in-type-2-diabetesAmycretin Shows Significant Weight Loss, HbA1c ...
Amycretin achieved significant HbA1c reductions and weight loss in patients with type 2 diabetes, with dose-dependent effects observed in ...
Amycretin, a novel, unimolecular GLP-1 and amylin ...
An ongoing phase 2 study (NCT06542874 ) will evaluate the safety, tolerability, and efficacy of amycretin in people living with type 2 diabetes ...
The effect of amycretin, a unimolecular glucagon-like ...
Amycretin had various beneficial effects on metabolic health in mice and rats; effectively reducing body weight, enhancing insulin sensitivity, ...
Subcutaneous Amycretin Shows Weight Loss of 9.7% for ...
Amycretin, a unimolecular glucagon-like peptide-1 (GLP-1) and amylin receptor agonist, showed an estimated body weight loss of 9.7% with a 1.25 mg dose (20 ...
6.
thelancet.com
thelancet.com/cms/10.1016/S0140-6736(25)01176-6/attachment/19b6df90-918f-41b8-a295-bf4ad1578f38/mmc1.pdfSupplementary appendix
PK modelling based on NNC0487-0111 concentration data from the study will be performed. Model development will initially be based on interim ...
Amycretin Trial Shows Promising Weight Loss Results
The novel GLP-1 and amylin receptor agonist amycretin appears to be safe and tolerable and results in significant reductions in body weight ...
amycretin oral (NN9487 oral) News
In people with overweight or obesity, amycretin appeared safe and tolerable. Results from this first-in-human, phase 1 study support further investigation of ...
NCT06542874 | A Research Study Comparing How Well ...
The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes.
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