GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 2

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

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

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

142

actual

Study population

Diabetic neuropathy, Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c ≤10.5%

Primary endpoint

•Weekly average Pain Intensity-Numerical Rating Scale (PI-NRS)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06797869

Org study IDNN9388-7864

Secondary ID2023-509662-38European Medical Agency (EMA)

Secondary IDU1111-1306-9422World Health Organization (WHO)

Timeline

Milestones

Study first posted2025-01-29actual

Study start2025-01-29actual

Last update posted2025-12-05actual

Primary completion2026-08-21estimated

Study completion2026-08-21estimated

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Diabetic neuropathyType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Key Inclusion Criteria:

•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.

–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).

Key Exclusion Criteria:

•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.

•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.

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Other clinical outcomes

Safety / tolerability / PK

Patient-reported / QoL

Weight & body composition

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Relative change in body weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

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

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

10 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Ratio to Baseline in Lipids: Total Cholesterol

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

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

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

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

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

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

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

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

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

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

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline in Lipids: Triglycerides

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

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to Baseline in Lipids: Free fatty acids

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

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline in Lipids: Non-HDL cholesterol

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

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

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

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

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

3 endpoints

Primary/protocol endpoint

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

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

change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Secondary/protocol endpoint

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

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

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of treatment-emergent adverse events (TEAEs)

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment-emergent serious adverse events (TESAEs)

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

Serious AEs (any)

event count, event

Secondary/protocol endpoint

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

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

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

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

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

Documented hypoglycemia

event count, event

Other clinical outcomes

5 endpoints

Secondary/protocol endpoint

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

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

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

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

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

time to event, improvement

Secondary/protocol endpoint/low confidence

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

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

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

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

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

time to event, improvement

Secondary/protocol endpoint

Change in Michigan Neuropathy Screening Instrument (MNSI)

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.