NNC0487-0111 for Obesity
(AMAZE 1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called NNC0487-0111, an experimental drug, to determine its safety and effectiveness for individuals with excess body weight. The treatment involves weekly injections and is compared to a placebo, which contains no active medicine. Participants will also follow a reduced-calorie diet and increase physical activity. Individuals who have unsuccessfully attempted weight loss through dieting at least once may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the development of a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain diabetes medications like GLP-1 treatments.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that NNC0487-0111 is generally safe for individuals who are overweight. In earlier studies, participants received this treatment as a weekly injection under the skin. These studies examined the treatment's mechanism and safety.
Previous results indicated that participants tolerated NNC0487-0111 well. Side effects were mild, with some experiencing reactions like nausea or headache, common with similar treatments. Importantly, a recent study with a different group also found the treatment safe, with no serious issues reported.
Since NNC0487-0111 is in advanced testing stages, its safety appears well-established. However, ongoing studies aim to confirm these results. Always consult a healthcare provider to understand the implications of joining a trial.12345Why do researchers think this study treatment might be promising for obesity?
Unlike the standard treatments for obesity, which often include oral medications and lifestyle changes, NNC0487-0111 is unique because it is administered via a once-weekly subcutaneous injection. This delivery method could provide a more consistent release of the drug, potentially leading to better adherence and outcomes. Researchers are excited about this treatment because it might offer a new approach by working in conjunction with a reduced-calorie diet and increased physical activity, potentially enhancing its effectiveness compared to existing options.
What evidence suggests that NNC0487-0111 might be an effective treatment for obesity?
Research has shown that NNC0487-0111, also known as amycretin, may aid in weight loss. One study found that participants taking a 60-mg dose of amycretin lost 24.3% of their weight, compared to a 1.1% loss in those taking a placebo. This trial will test NNC0487-0111 at various dose levels, with participants receiving it subcutaneously once weekly, alongside a reduced-calorie diet and increased physical activity. The treatment activates specific receptors to control appetite and boost metabolism. Animal studies have also indicated that amycretin can reduce body weight and improve insulin use. These findings suggest that NNC0487-0111 could be effective for weight management.23567
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 study is for men and women with excess body weight who have tried to lose weight through dieting without success. Participants must give informed consent and be willing to receive weekly injections. People are excluded if they don't meet these criteria or have conditions that could interfere with the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive NNC0487-0111 or placebo as weekly subcutaneous injections along with a reduced-calorie diet and increased physical activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- NNC0487-0111
Trial Overview
The trial is testing NNC0487-0111, a new medicine given as a weekly injection under the skin, against a placebo (a substance with no active medication). The assignment of either NNC0487-0111 or placebo to participants is random.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Participants will receive 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
AMAZE 1: A Research Study Investigating How Well the ...
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.
A Research Study on How NNC0487-0111, a New ...
The study is testing a new medicine (NNC0487-0111) for weight control in Chinese people with BMI between 24 kilogram per meter square (kg/m2) and 34.9 kg/m2.
Amycretin Trial Shows Promising Weight Loss Results
The study demonstrated significantly higher weight reduction from baseline with amycretin versus placebo (60-mg group, -24.3% vs -1.1% at week ...
Amycretin, a novel, unimolecular GLP-1 and amylin ...
Amycretin (NNC0487-0111) is a unimolecular peptide agonist of GLP-1, amylin, and calcitonin receptors, with the potential to enhance weight ...
The effect of amycretin, a unimolecular glucagon-like peptide ...
Amycretin had various beneficial effects on metabolic health in mice and rats; effectively reducing body weight, enhancing insulin sensitivity, ...
A Research Study on How NNC0487-0111 Works in ...
This study tests if the study medicine is safe and to find out how the medicine works in humans. This study also look at how the study medicine affects body ...
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thelancet.com
thelancet.com/cms/10.1016/S0140-6736(25)01176-6/attachment/19b6df90-918f-41b8-a295-bf4ad1578f38/mmc1.pdfSupplementary appendix
doses of NNC0487-0111 in participants with overweight or obesity. Objectives and endpoints: Part A. Primary objective and endpoint ...
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