CagriSema for Diabetic Neuropathy

Recruiting at 60 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

Must be taking: Oral anti-diabetics, Basal insulin

Must not be taking: GLP-1 RA, Opioids

Disqualifiers: Pregnancy, Epilepsy, Fibromyalgia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new medicine, CagriSema, for individuals with type 2 diabetes experiencing painful diabetic nerve damage in their feet and hands. Participants will randomly receive either CagriSema or a placebo ("dummy" medicine). The goal is to determine if CagriSema reduces nerve pain compared to no active treatment. Individuals with type 2 diabetes who have experienced nerve pain for at least three months and are on stable pain treatment may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that your diabetes and pain treatments are stable for at least 3 months before screening. Some medications, like glucagon-like peptide-1 receptor agonists, must be stopped 60 days before screening.

Is there any evidence suggesting that CagriSema is likely to be safe for humans?

Research has shown that CagriSema, a combination of cagrilintide and semaglutide, has been tested in studies for weight and diabetes-related conditions. These studies generally found it to be well-tolerated. One study found that CagriSema led to significant weight loss and had fewer reports of vomiting compared to similar treatments, suggesting its side effects might be milder than those of other weight loss drugs.

However, since this study is in an early phase, only some safety information is available. More data is needed to fully understand its safety in different conditions, such as diabetic neuropathy. Participants should consider this when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for diabetic neuropathy focus on symptom relief and include medications like pain relievers and antidepressants. Unlike these standard options, CagriSema combines two active ingredients, Cagrilintide B and Semaglutide I, which are administered together through a weekly injection. This combination is exciting because it potentially targets the underlying metabolic issues of diabetes that contribute to nerve damage, rather than just managing pain. Researchers are hopeful that CagriSema could offer a dual approach by addressing both blood sugar levels and directly impacting nerve health, a novel mechanism compared to current treatments.

What evidence suggests that CagriSema might be an effective treatment for diabetic neuropathy?

Research has shown that CagriSema, a combination of cagrilintide and semaglutide, may aid in weight loss and diabetes management. Studies found that individuals using CagriSema reduced their A1C levels, which measure long-term blood sugar, by an average of 2.2 percentage points and lost nearly 16% of their body weight. These outcomes are significant because improved blood sugar control and weight loss can enhance the management of type 2 diabetes. Although CagriSema is not yet approved for treating nerve pain caused by diabetes, its effects on diabetes and weight suggest it could be a valuable treatment. Further research is necessary to confirm its benefits for painful diabetic nerve issues. Participants in this trial will receive either CagriSema or a placebo to further explore its potential benefits for diabetic neuropathy. ^{1 2 3 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 also suffer from painful diabetic peripheral neuropathy. Participants will be involved in the study for approximately 10 months.

Inclusion Criteria

I am either male or female.

Body mass index (BMI) ≥25.0 kilogram per square meter (kg/m^2) at screening

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

Exclusion Criteria

I haven't used opioids, cannabinoids, or benzodiazepines heavily in the last month.

I don't plan to change my medications that affect weight or blood sugar during the study.

I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CagriSema or placebo subcutaneously once weekly. CagriSema is administered in a dose escalation manner for 16 weeks followed by a maintenance dose for another 16 weeks.

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CagriSema

Trial Overview The study is testing the effects of a new medication called CagriSema against a placebo (a 'dummy' medicine with no active ingredients). Patients are randomly assigned to receive either CagriSema or the placebo.

How Is the Trial Designed?

Group I: CagriSema Experimental Treatment 1 Intervention

Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.

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

Curcuma caesia has potential therapeutic benefits for diabetic neuropathy due to its antioxidant properties, which can reduce oxidative stress, a key factor in the condition's development.

Additionally, its anti-inflammatory and antibacterial effects may help prevent neuron inflammation and infection, suggesting that this plant could be a valuable treatment option for managing diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the utility of Curcuma caesia in the treatment of diabetic neuropathy. Grover, M., Shah, K., Khullar, G., et al.[2019]

Nishamalaki (NA), a combination of Curcuma longa and Emblica officinalis, significantly improved symptoms of diabetic neuropathy in type 2 diabetic rats, showing better efficacy than standard treatments like Glibenclamide, Epalrestat, and Pioglitazone at higher doses.

NA not only helped in controlling blood sugar levels and improving lipid profiles but also effectively prevented the development of diabetic neuropathy, indicating its potential as a therapeutic option for managing diabetic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Effect of Nishamalaki on STZ and HFHF Diet Induced Diabetic Neuropathy in Wistar Rats. Dawane, JS., Pandit, VA., Bhosale, MS., et al.[2020]

Diabetic neuropathy is a major complication of both type 1 and type 2 diabetes, affecting the autonomic nerves and leading to diabetic autonomic neuropathy.

The mechanisms behind diabetic neuropathy are thought to involve metabolic, vascular, and immunological factors, with many patients showing autonomic function abnormalities even without clinical symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Autonomic neuropathy in diabetic patients. Part I. Pathogenesis and clinical problems]. Otto-Buczkowska, E., Chobot, PJ.[2006]

In a study of 60 patients with symmetric diabetic polyneuropathy, those treated with cerebrolysin showed significant improvement in polyneuropathic symptoms compared to those receiving milgamma.

The effectiveness of cerebrolysin was assessed using the Diabetic Polyneuropathy Scale and the Neuropathy Disability Score, indicating its potential as a beneficial treatment option for managing diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of cerebrolysin therapy on the dynamics of diabetic polyneuropathy symptoms]. Bogdanov, EI., Sakovets, TG., Gil'mullin, IF.[2016]

Meticulous control of blood glucose is the only consistently beneficial strategy for treating diabetic neuropathy, as shown in the Diabetes Control and Complications Trial with 1,500 patients, which delayed the onset and slowed the progression of neuropathy.

While glycemic control is crucial, there are concerns about the methods used to measure improvement in neuropathy and the risks of severe hypoglycemia, which can worsen nerve damage; thus, additional strategies, like aldose reductase inhibitors, are needed to further protect nerves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diabetic neuropathy. Parry, GJ.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06797869

NCT06797869 | A Research Study to Investigate the ... This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, ...

2. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2502081

Coadministered Cagrilintide and Semaglutide in Adults ... Cagrilintide–semaglutide provided significant and clinically relevant body-weight reductions in adults with overweight or obesity, as compared with placebo.

3. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9388-7864.html

A Research Study to Investigate the Effects of CagriSema ... This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11642503/

Efficacy and Safety of Cagrilintide Alone and in ... The primary outcome was changes in body weight. Secondary outcomes were alterations in fasting plasma glucose (FPG) and glycated haemoglobin ( ...

5. diatribe.org diatribe.org/diabetes-research/join-ongoing-trials-type-2-diabetes-and-obesity

CagriSema: Ongoing Trials for Type 2 Diabetes and Obesity Recent studies have found that participants taking CagriSema reduced their A1C by an average of 2.2 percentage points and lost almost 16% of their body weight.

6. hcplive.com hcplive.com/view/ada-2025-cagrisema-demonstrates-dual-benefit-in-obesity-and-type-2-diabetes

ADA 2025: CagriSema Demonstrates Dual Benefit in ... CagriSema showed superior weight reduction in REDEFINE 1 and 2 trials, outperforming existing interventions. · REDEFINE 1 reported a 20.4% mean ...

7. pharmacytimes.com pharmacytimes.com/view/co-formulation-of-semaglutide-and-cagrilintide-shows-promise-against-diabetes-and-obesity

Co-formulation of Semaglutide and Cagrilintide Shows ... In terms of efficacy, the combination of cagrilintide and semaglutide appears to outperform GLP-1 receptor agonists alone, particularly for ...