Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy

NCT07706088 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tirzepatide is a dual agonist of GLP-1 Receptor and the GIP receptor, producing substantial improvement in glycaemic control, weight reduction and insulin sensitivity. Beyond its metabolic effects, incretin signalling has demonstrated neuroprotective and neurotropic properties, including activation of intracellular pathways that enhance neuronal survival and regeneration. Using tirzapatide for diabetic sensorimotor peripheral neuropathy and assessing with CCM / NCS and BDNF will represent three complementary aspects of nerve regeneration: metabolic control, structural nerve repair and neurotrophic signalling.

Conditions

Neuropathy, Small Fiber; Diabete Mellitus

Keywords

diabetes; neuropathy; tirzepatide

Outcome Measures

Primary Outcomes (1)

• To assess the percent change in CNFD compared to baseline

  6 months

Secondary Outcomes (1)

• corneal confocal microscopy

  6 months

Study Arms (2)

patients with diabetic peripheral neuropathy to receive standard of care including tirzepatide

EXPERIMENTAL

tirzepatide drug being given to diabetic patients with peripheral neuuropathy

Drug: Tirzepatide 2.5mg weekly

diabetic patients recieving standard care without use of tirzepatide

ACTIVE COMPARATOR

all standard care except tirzepatide

Drug: all standard of care to diabetic patient besides tirzepatide

Interventions

Tirzepatide 2.5mg weekly DRUG

tirzepatide will be initiated at 2.5 mg weekly and dose will be escalated to 7.5 mg weekly depending upon tolerance and changes in parameters from baseline as described as outcomes

patients with diabetic peripheral neuropathy to receive standard of care including tirzepatide

all standard of care to diabetic patient besides tirzepatide DRUG

diabetic patient will receive all standard of care beside tirzepatide

diabetic patients recieving standard care without use of tirzepatide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants (≥ 18 years) with diabetes duration of \< 10 years, baseline HbA1c between 7% and 10% Signs and symptoms of DSPN based on a Michigan Neuropathy Screening Instrument (MNSI) history composite score of \>= 7 OR MNSI examination SCORE \>= 2.5 will be enrolled.
• BMI \>= 27 KG/metre 2.

You may not qualify if:

• participants with untreated hypothyroidism
• history of leprosy
• peripheral vascular disease defined by ankle-brachial index (ABI) \&lt; 0.9
• serum B12 levels \< 200 pg./mL/ if low will be supplemented
• history of alcohol excess (\>=2 and \>= 1 standard drink per day for male and female respectively)
• any condition affecting corneal nerves (severe dry eyes, severe corneal dystrophies, ocular trauma or surgery in the preceding 6 months or Sjogren\&#39;s or sicca syndrome
• use of oral contraceptives.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

MeSH Terms

Conditions

Small Fiber Neuropathy; Diabetes Mellitus

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: effect of tirzepatide on diabetic peripheral sensorimotor neuropathy

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07