NNC0487-0111 for Type 2 Diabetes

Recruiting at 86 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

Must be taking: Metformin, SGLT2 inhibitors

Must not be taking: Diabetes, obesity medications

Disqualifiers: Uncontrolled diabetic retinopathy, hypoglycaemic unawareness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

432 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively different doses of a new medicine, NNC0487-0111, can lower blood sugar and body weight in people with type 2 diabetes. Participants will receive this medicine as tablets or injections, or they will receive a placebo (a non-active treatment). The trial seeks individuals diagnosed with type 2 diabetes for at least 180 days who are on a stable dose of metformin, with or without an SGLT2 inhibitor, and who are willing to wear a glucose monitor during the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in diabetes care.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it requires that you have been on a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days before joining. Other diabetes or obesity medications are not allowed within 90 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that NNC0487-0111 has been tested in people before, both as an injection under the skin and as a pill. In earlier studies, most people tolerated the treatment well, though some experienced mild side effects.

For the injection form, studies found it safe, with no major safety issues, though some participants reported minor problems.

The pill form also appeared safe and easy to handle. Participants experienced significant weight loss after 36 weeks, which is encouraging.

Overall, while some side effects might occur, past research suggests that NNC0487-0111 is generally safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about NNC0487-0111 for type 2 diabetes because it offers a novel approach compared to existing treatments like metformin, sulfonylureas, and insulin therapy. NNC0487-0111 can be administered both orally and subcutaneously, providing flexible dosing options that cater to different patient needs and preferences. Additionally, the treatment is being tested in multiple doses, which might help optimize its effectiveness and minimize side effects. This flexibility and potential for tailored treatment make NNC0487-0111 a promising candidate in diabetes management.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that NNC0487-0111, which participants in this trial may receive, could benefit people with type 2 diabetes. Studies have found that medicines like NNC0487-0111, such as GLP-1 and amylin receptor agonists, can lower blood sugar and aid in weight loss. Early results from previous trials suggested that NNC0487-0111 might work similarly. Although still in the early stages, this treatment targets specific processes in the body to achieve these benefits, potentially leading to better blood sugar control and weight management. ^{1 3 5 6 7}

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 individuals with type 2 diabetes who are interested in testing a new medication, NNC0487-0111. Participants will be involved in the study for approximately 43 weeks and must meet specific health criteria to join.

Inclusion Criteria

I was diagnosed with type 2 diabetes more than 6 months ago.

Body mass index between greater or equal to 23.0 and below 50.0 kg/m^2

Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study

Exclusion Criteria

I have severe diabetic eye problems that are not under control.

Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question

I haven't taken diabetes or obesity drugs not listed in the criteria in the last 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NNC0487-0111 or placebo, administered as tablets or injections, to evaluate the effect on blood sugar and body weight

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NNC0487-0111

Trial Overview The study tests how well different doses of NNC0487-0111 lower blood sugar and body weight when administered orally or by injection compared to a placebo. Treatment assignments are randomized.

How Is the Trial Designed?

Group I: NNC0487-0111 subcutaneous dose 6 Experimental Treatment 1 Intervention

NNC0487-0111 subcutaneous dose 6 treatment

Group II: NNC0487-0111 subcutaneous dose 5 Experimental Treatment 1 Intervention

NNC0487-0111 subcutaneous dose 5 treatment

Group III: NNC0487-0111 subcutaneous dose 4 Experimental Treatment 1 Intervention

NNC0487-0111 subcutaneous dose 4 treatment

Group IV: NNC0487-0111 subcutaneous dose 3 Experimental Treatment 1 Intervention

NNC0487-0111 subcutaneous dose 3 treatment

Group V: NNC0487-0111 subcutaneous dose 2 Experimental Treatment 1 Intervention

NNC0487-0111 subcutaneous dose 2 treatment

Group VI: NNC0487-0111 subcutaneous dose 1 Experimental Treatment 1 Intervention

NNC0487-0111 subcutaneous dose 1 treatment

Group VII: NNC0487-0111 oral dose 3 Experimental Treatment 1 Intervention

NNC0487-0111 oral dose 3 treatment

Group VIII: NNC0487-0111 oral dose 2 Experimental Treatment 1 Intervention

NNC0487-0111 oral dose 2 treatment

Group IX: NNC0487-0111 oral dose 1 Experimental Treatment 1 Intervention

NNC0487-0111 oral dose 1 treatment

Group X: Placebo oral Placebo Group 1 Intervention

Placebo for oral treatment

Group XI: Placebo subcutaneous Placebo Group 1 Intervention

Placebo for subcutaneous treatment

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

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

Published Research Related to This Trial

Incretin therapies are emerging treatments for type 2 diabetes (T2D) that could provide new options for patients, especially as the disease is increasingly diagnosed at younger ages in the UK.

The article emphasizes the importance of understanding the clinical evidence and recommendations for incretin therapies, which can help diabetes nurses offer more effective treatment strategies for managing T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incretin-based therapies for type 2 diabetes: a nurse's perspective. Hodgkiss, J.[2011]

NN2211, a long-acting GLP-1 derivative, effectively reduced blood glucose levels in ob/ob and db/db mice, showing sustained antihyperglycemic effects for 24 hours after administration.

In db/db mice, NN2211 not only decreased blood glucose but also significantly increased beta-cell mass and proliferation, suggesting a potential mechanism for improved insulin production, while body weight remained unchanged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The long-acting GLP-1 derivative NN2211 ameliorates glycemia and increases beta-cell mass in diabetic mice. Rolin, B., Larsen, MO., Gotfredsen, CF., et al.[2018]

In a study involving 11 patients with type 2 diabetes, the long-acting GLP-1 derivative NN2211 significantly reduced fasting plasma glucose levels and meal-related glucose levels, demonstrating its efficacy as a glucose-lowering agent.

NN2211 works by increasing insulin secretion, delaying gastric emptying, and suppressing glucagon secretion, with a half-life of about 10 hours, indicating its potential for effective management of blood sugar levels in diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bedtime administration of NN2211, a long-acting GLP-1 derivative, substantially reduces fasting and postprandial glycemia in type 2 diabetes. Juhl, CB., Hollingdal, M., Sturis, J., et al.[2022]

In a study involving 210 subjects with Type 2 diabetes, liraglutide, a once-daily GLP-1 analogue, showed improvements in glycaemic control and weight loss comparable to metformin, particularly at higher doses.

Liraglutide was found to be safe and well tolerated, with no major hypoglycaemic episodes reported, although some patients experienced mild nausea or vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. Feinglos, MN., Saad, MF., Pi-Sunyer, FX., et al.[2022]

The U.S. FDA has approved six classes of oral medications for type 2 diabetes, with metformin and lifestyle changes recommended as the first-line treatments according to a consensus by the American Diabetes Association and the European Association for the Study of Diabetes.

New therapies in development, including incretin therapies and agents targeting metabolic syndrome, show promise for improving treatment options for type 2 diabetes, especially for patients struggling with weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes: new and future developments in treatment. Liao, EP.[2022]

In a study involving 10 subjects with type 2 diabetes, the long-acting GLP-1 derivative NN2211 significantly increased insulin secretion and improved beta-cell responsiveness to glucose compared to placebo.

NN2211's effects on insulin secretion rates were comparable to those observed in nondiabetic individuals, suggesting it effectively mimics normal physiological responses to elevated blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The GLP-1 derivative NN2211 restores beta-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Chang, AM., Jakobsen, G., Sturis, J., et al.[2019]

In a study of 63 newly diagnosed type 2 diabetes patients treated for 12 weeks, liraglutide showed better control of blood glucose fluctuations compared to NPH, with significant reductions in measures like MAGE and SDBG.

While liraglutide and NPH both improved overall glycemic control similarly, liraglutide had a lower incidence of hypoglycemia and was associated with gastrointestinal side effects and some weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of liraglutide vs. NPH in combination with metformin on blood glucose fluctuations assessed using continuous glucose monitoring in patients with newly diagnosed type 2 diabetes. Ma, Z., Chen, R., Liu, Y., et al.[2022]

Incretin-based therapies, including oral DPP-4 inhibitors and injectable GLP-1 receptor agonists, are effective in managing Type 2 diabetes by improving glycemic control and aiding in weight management, particularly addressing the reduced incretin effect seen in diabetic patients.

These therapies not only help regulate blood sugar levels but also show potential benefits for inflammation, cardiovascular health, liver function, sleep, and brain health, indicating a broader impact beyond just diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incretin-based therapies. Stonehouse, AH., Darsow, T., Maggs, DG.[2022]

Incretin-based therapies, particularly GLP-1 analogues and DPP-4 inhibitors, have significantly improved the management of type 2 diabetes by effectively lowering hemoglobin A1c levels, promoting weight loss, and having a low risk of hypoglycemia.

Recent meta-analyses have alleviated concerns regarding an elevated risk of pancreatitis associated with these therapies, confirming their safety and tolerability compared to other diabetes medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incretin manipulation in diabetes management. Pappachan, JM., Raveendran, AV., Sriraman, R.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06542874

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40550229/

a first-in-human, phase 1, double-blind, randomised ... Results from this first-in-human, phase 1 study support further investigation of the weight loss properties of amycretin. Funding: Novo Nordisk ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01176-6/abstract

a first-in-human, phase 1, double-blind, randomised ... GLP-1 receptor agonists and amylin receptor agonists have shown clinically relevant weight loss and glucose-lowering effects in people with ...

4. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9490-7678.html

A Research Study Comparing How Well Different Doses of ... 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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625011857

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 ...

6. 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.pdf

Amycretin, a novel, unimolecular glucagon-like peptide-1 and ... Data are for the safety analysis set. †Sex was self-reported by participants. BMI, body mass index; HbA1c, glycated haemoglobin; n, number of ...

7. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01185-7/abstract

results from a phase 1b/2a randomised controlled study The aim of this study was to investigate the safety, tolerability, pharmacokinetics, and effects on bodyweight of subcutaneous amycretin ...