NNC0487-0111 for Obesity
(AMAZE 12 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 effectiveness for individuals with excess body weight. Participants will receive weekly injections of either the treatment or a placebo (a treatment with no active medicine) to evaluate its efficacy alongside a reduced-calorie diet and increased physical activity. The trial aims to assess the safety and effectiveness of the treatment in reducing weight. It seeks adults who do not have diabetes and are not currently using certain weight-related medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that NNC0487-0111 was generally safe in earlier studies. People with obesity managed it well, with most side effects being mild. Importantly, these trials have not identified any new safety issues. As the treatment undergoes further testing, researchers will continue to closely monitor safety as more participants join the studies.12345
Why do researchers think this study treatment might be promising?
NNC0487-0111 is unique because it is administered as a once-weekly subcutaneous injection, which can offer more convenience compared to daily oral medications for obesity. Unlike most treatments that focus on appetite suppression or calorie absorption reduction, this experimental drug works in conjunction with a reduced-calorie diet and increased physical activity to potentially enhance weight loss results. Researchers are excited about NNC0487-0111 because it may provide a more effective and manageable option for people struggling with obesity, potentially leading to better adherence and outcomes.
What evidence suggests that NNC0487-0111 might be an effective treatment for obesity?
Research has shown that NNC0487-0111, also known as amycretin, yields promising results for weight loss. In this trial, participants will receive either NNC0487-0111 or a placebo. Previous studies demonstrated that individuals taking amycretin lost significantly more weight than those on a placebo. For instance, one group lost up to 24.3% of their weight. Another study reported weight loss of up to 22% over various time periods. Amycretin affects GLP-1 and amylin receptors, which help control appetite and metabolism. These findings suggest that amycretin could effectively reduce excess body weight.46789
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants reach the target dose during the run-in period
Treatment
Participants receive weekly subcutaneous injections of NNC0487-0111 or placebo as an adjunct to 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
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Participants will receive subcutaneous injection of placebo matched to NNC0487-0111 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
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 ...
Recent phase 1 clinical trial data have reported that oral amycretin appeared safe and tolerable (most treatment-emergent adverse events were ...
3.
pharmacytimes.com
pharmacytimes.com/view/novo-nordisk-announces-topline-results-for-amycretin-as-potential-obesity-overweight-treatmentNovo Nordisk Announces Top-Line Results for Amycretin ...
Amycretin (Novo Norisk) led to a reduction in body weight across the 20-week, 28-week, and 36-week periods, with weight loss of up to 22%.
NNC0487-0111 for Obesity · Info for Participants
Research has shown that the drug NNC0487-0111, also known as amycretin, may aid in weight loss. In one study, participants taking 100 mg of amycretin daily lost ...
5.
sciencehub.novonordisk.com
sciencehub.novonordisk.com/content/dam/sciencehub/global/en/congresses-and-scientific-publications/congresses/easd2025/dahl/documents/Dahl_EASD25_s_c_amycretin_oral_presentation_09SEP25.pdfDahl_EASD25_s_c_amycretin_o...
Amycretin (NNC0487-0111) is a unimolecular GLP-1 and amylin receptor ... Percentage body weight change. Data are for the full analysis set.
A Research Study Looking at How NNC0487-0111 Affects ...
The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when ...
AMAZE 12: 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.
8.
ctv.veeva.com
ctv.veeva.com/study/a-research-study-to-see-how-a-new-medicine-nnc0487-0111-works-in-people-with-overweight-or-obesityA Research Study to See How a New Medicine (NNC0487 ...
The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under ...
9.
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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