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Diabetes Mellitus, Type 2Phase 2NCT06797869

A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy

A Phase 2 study testing CagriSema (Cagrilintide B and Semaglutide I) in people with Diabetes Mellitus, Type 2 and Diabetic Peripheral Neuropathy, run by Novo Nordisk A/S at 55 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CagriSema (Cagrilintide B and Semaglutide I)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
55 sitesin 7 countries
Study dates
29 Jan 2025to 5 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female.
  • Age 18 years or above at the time of signing the informed consent.
  • Body mass index (BMI) ≥25.0 kilogram per square meter (kg/m^2) at screening.
  • Diagnosis of type 2 diabetes (T2D) ≥180 days before screening.
  • -- For participants on anti-diabetic drugs: Stable daily and/or weekly dose(s) ≥90 days before screening of any of the following anti-diabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose, as judged by the investigator:
  • Treatment with 1-3 marketed oral anti-diabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i), thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local guidelines.
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  • Treatment with basal or basal-bolus insulin (including premixed insulin formulations) according to local guidelines.
  • HbA1c ≤10.5 % (91 millimole per mole [mmol/mol]) and ≥6.0 % (42 mmol/mol), as determined by central laboratory at screening.
  • Diagnosis of painful diabetic peripheral neuropathy (pDPN) at screening as well as at the following criteria:
  • -- Participant with self-reported pain consistent with pDPN for a minimum of 3 months before screening, as judged by the investigator.
  • Stable pharmacological and non-pharmacological treatment of pain for a minimum of 3 months before screening, in the opinion of the investigator. The treatment regimen should adhere to local guidelines (if available).

Who cannot join

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  • Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, (DPP-4), or amylin analogue within 60 days before screening.
  • Significant use of opioids, cannabinoids or benzodiazepines within 30 days before screening, in the opinion of the investigator. Significant use is defined as use that renders it unlikely that the participant is able to comply with protocol requirements for discouraged medications.
  • Anticipated initiation or clinically relevant change in concomitant medications (for more than 14 consecutive days during the study) known to affect weight or glucose metabolism (e.g., orlistat, thyroid hormones or oral corticosteroids).
  • Planned initiation or change in anti-depressant, anti-psychotic or anti-epileptic medication. If participants are already taking such medication, they should have stable and optimised treatment for at least 8 weeks before screening.
  • Presence or history of epilepsy and fibromyalgia.
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  • Presence of non-diabetic neuropathies, in the opinion of the investigator.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination and OCT assessment performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Any other painful medical condition(s) where the pain is significantly more severe than the diabetic peripheral neuropathy pain, as judged by the investigator (participants will not be excluded if the pain is transient in nature).
  • History of suicidal attempt within 5 years before screening
  • Suicidal behaviour within 1 month before screening.
  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73 m2 as determined by central laboratory at screening.
  • Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.

Trial locations and contacts

55 sites in 7 countries.

55 sites in 7 countries

United States20 sites

  • DM Clinical

    Albuquerque, New Mexico, 87106

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • DM Clinical

    Houston, Texas, 77081

  • eStudySite

    La Mesa, California, 91942

  • Radiance Clinical Research

    Lampasas, Texas, 76550

  • My Preferred Research

    Miami, Florida, 33155

  • New Horizon Research Center

    Miami, Florida, 33165

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Velocity Clinical Research Rockville

    Rockville, Maryland, 20854

  • DM Clinical Research

    San Antonio, Texas, 78207

  • DM Clinical

    San Antonio, Texas, 78207

  • Linda Vista Health Care Ctr

    San Diego, California, 92111

  • Foot & Ankle Center of Illinois

    Springfield, Illinois, 62704

  • Amicis Centers of Clinical Research

    St Louis, Missouri, 63128

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625

  • Velocity Clinical Research Portsmouth

    Suffolk, Virginia, 23435

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

Other trials in United States

Canada7 sites

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Centricity Clinical Research Burlington

    Burlington, Ontario, L7M 4Y1

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8L 5G4

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2

Other trials in Canada

Spain7 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Nisa Sevilla Aljarafe (To be inactivated when NN9388-7864 is in closing status)

    Castilleja de la Cuesta, Andalusia, 41950

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • H. Infanta Luisa_Endocrino y Obesidad

    Seville, 41010

Other trials in Spain

United Kingdom7 sites

  • Tameside General Hospital

    Ashton-under-Lyne, Greater Manchester, OL6 9RW

  • Ipswich Hospital - Diabetes

    Ipswich, IP4 5PD

  • Aintree University Hospital

    Liverpool, L9 7AL

  • St Pancras Clinical Research

    London, EC2Y 8EA

  • King's College Hospital - Renal

    London, SW9 8RR

  • Manchester Royal Infirmary - Diabetes

    Manchester, M13 9WL

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

Denmark5 sites

  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

    Aarhus N, 8200

  • Steno Diabetes Center Nordjylland

    Gistrup, 9260

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

  • Kolding Sygehus Karkirurgi

    Kolding, 6000

  • Steno Diabetes Center Odense

    Odense C, 5000

Other trials in Denmark

France5 sites

  • Les Hopitaux de Chartres-Hopital Louis Pasteur

    Le Coudray, 28630

  • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu

    Le Creusot, 71200

  • Aphp-Hopital La Pitie Salpetriere

    Paris, 75013

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque

    Pessac, 33600

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200

Other trials in France

Norway4 sites

  • Haukeland Universitetssykehus

    Bergen, 5021

  • Sykehuset Innlandet HF Hamar

    Hamar, 2318

  • Oslo universitetssykehus, Ullevål

    Oslo, 0450

  • Stavanger Universitetssykehus, Helse Stavanger HF

    Stavanger, NO-4011

Other trials in Norway

About this study

Official title: Efficacy and Safety of co Administered Cagrilintide and Semaglutide (CagriSema) Once Weekly Versus Placebo in Participants With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy

This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.

Being tested
CagriSema (Cagrilintide B and Semaglutide I), Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagriSema (Cagrilintide B and Semaglutide I)Drug

    Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

  • Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)Drug

    Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Study groups in NCT06797869
Study groupRoleWhat they receive
CagriSemaExperimentalParticipants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.
Receives: Drug: CagriSema (Cagrilintide B and Semaglutide I)
PlaceboPlacebo comparatorParticipants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.
Receives: Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS)

    Measured as score on a scale.

    Measured: From baseline (week 0) to end of treatment (week 32)

Secondary outcomes (25)

  1. Number of participants reaching ≥30 percentage (%) reduction in PI-NRS

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 32)

  2. Time to achieve ≥30% reduction in weekly average PI-NRS

    Measured as days.

    Measured: From baseline (week 0) to end of treatment (week 32)

  3. Number of participants reaching ≥50 % reduction in PI-NRS

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 32)

  4. Time to achieve ≥50% reduction in weekly average PI-NRS

    Measured as days.

    Measured: From baseline (week 0) to end of treatment (week 32)

  5. Change in Brief Pain Inventory-Short Form (BPI-SF)

    Measured as score on a scale.

    Measured: From baseline (week 0) to end of treatment (week 32)

  6. Change in Chronic Pain Sleep Inventory 3-item (CPSI 3)

    Measured as score on a scale.

    Measured: From baseline (week 0) to end of treatment (week 32)

  7. Change in Michigan Neuropathy Screening Instrument (MNSI)

    Measured as score on a scale.

    Measured: From baseline (week 0) to end of treatment (week 32)

  8. Change in systolic blood pressure

    Measured as millimeters of mercury (mmHg).

    Measured: From baseline (week 0) to end of treatment (week 32)

  9. Change in diastolic blood pressure

    Measured as mmHg.

    Measured: From baseline (week 0) to end of treatment (week 32)

  10. Change in glycated haemoglobin (HbA1c)

    Measured as percentage of HbA1c.

    Measured: From baseline (week 0) to end of treatment (week 32)

  11. Change in Fasting Plasma Glucose (FPG)

    Measured as millimole per liter (mmol/L).

    Measured: From baseline (week 0) to end of treatment (week 32)

  12. Relative change in body weight

    Measured as percentage change.

    Measured: From baseline (week 0) to end of treatment (week 32)

  13. Change in waist circumference

    Measured as centimeter (cm).

    Measured: From baseline (week 0) to end of treatment (week 32)

  14. Ratio to Baseline in Lipids: Total Cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 32)

  15. Ratio to Baseline in Lipids: High-density lipoprotein (HDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 32)

  16. Ratio to Baseline in Lipids: Low-density lipoprotein (LDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 32)

  17. Ratio to Baseline in Lipids: Very low-density lipoprotein (VLDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 32)

  18. Ratio to Baseline in Lipids: Triglycerides

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 32)

  19. Ratio to Baseline in Lipids: Free fatty acids

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 32)

  20. Ratio to Baseline in Lipids: Non-HDL cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to end of treatment (week 32)

  21. Relative change in high sensitivity C-reactive protein (hsCRP)

    Measured as percentage change.

    Measured: From baseline (week 0) to end of treatment (week 32)

  22. Number of treatment-emergent adverse events (TEAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 38)

  23. Number of treatment-emergent serious adverse events (TESAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 38)

  24. Number of severe hypoglycaemic episodes (level 3) (No specific glucose threshold)

    Severe hypoglycaemia is a severe event characterised by altered mental and/or physical status requiring assistance from another person to actively administer carbohydrates, glucagon, or take other corrective actions to treat hypoglycaemia. Measured as count of episodes.

    Measured: From baseline (week 0) to end of study (week 38)

  25. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by blood glucose meter))

    Measured as count of episodes.

    Measured: From baseline (week 0) to end of study (week 38)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start29 Jan 2025
  3. Primary completion26 Jun 2026
  4. Study completion5 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06797869
Sponsor's protocol ID
NN9388-7864
Other IDs
U1111-1306-9422, 2023-509662-38, 2023
Status last verified
Sep 2026
First submitted
27 Jan 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CagriSema (Cagrilintide B and Semaglutide I) in people with Diabetes Mellitus, Type 2 and Diabetic Peripheral Neuropathy, run by Novo Nordisk A/S at 55 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Canada, Spain, United Kingdom, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS) (time frame: From baseline (week 0) to end of treatment (week 32)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06797869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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Clinical Trial NCT06797869 | AzTrials