Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy

What Was Tested

The trial (phase 4) is built around Tirzepatide.

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.

It had two arms (groups): patients with diabetic peripheral neuropathy to receive standard of care including tirzepatide (experimental) and diabetic patients recieving standard care without use of tirzepatide (active comparator).

Tirzepatide drug being given to diabetic patients with peripheral neuuropathy.

All standard care except tirzepatide.

The registry classes the interventions as drug.

More on the Plan

The ADDITION Demark study reported that the prevalence of DPN was up to 34.8 (7).

The pathogenesis of DN is multifactorial and remains poorly understood.

DPN is characterized by progressive, nerve-length-dependent loss of peripheral nerve fibers, leading to impaired sensory and autonomic function, pain, numbness, and eventually, complete loss of sensation.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 7 exclusion criteria; among the exclusions: participants with untreated hypothyroidism; history of leprosy; peripheral vascular disease defined by ankle-brachial index (abi) \< 0.9.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Tirzepatide study did not mask who received what.

It started in 2026-07 with completion listed for 2028-07-01.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To assess the percent change in CNFD compared to baseline (time frame: 6 months).

It also tracked 1 secondary outcome, for example corneal confocal microscopy.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 40 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.