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Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis

Plain-language guide to NCT07443956: not phased randomized trial of Tirzepatide, psoriasis and psoriatic arthritis, 45 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07443956
Phase
not phased
Status
recruiting participants
Start
2026-03-09
Completion (planned or actual)
2028-02
Participants
45 (estimated)
Design
randomized, open label (everyone knows who gets what), basic_science
Conditions studied
Psoriatic Arthritis (PsA); Obesity & Overweight
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Tirzepatide for psoriasis and psoriatic arthritis.

This is a trial to find out how weight loss (achieved by the use of tirzepatide) or ixekizumab treatment affects the characteristics of skin, joint and fat tissues in patients with Psoriatic Arthritis, Psoriasis and obesity/overweight BMI \>=27.

Participants will be allocated either Tirzepatide, Ixekizumab or both.

Samples of joint tissue, fat and skin will be taken at the start of the study and week 12.

It had three arms (groups): Tirzepatide group (active comparator), Ixekizumab group (active comparator) and Combined tirzepatide and ixekizumab (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is a trial to find out how weight loss (achieved by the use of tirzepatide) or ixekizumab treatment affects the characteristics of skin, joint and adipose tissues in patients with Psoriatic Arthritis, Psoriasis and obesity/overweight BMI \>=27.

Patients will be randomised to three groups- tirzeparatide only, ixekizumab only or both drugs.

They will have an ultrasound guided synovial biopsy, a 4mm punch skin biopsy, alea skin tape sampling and a needle aspiration fat biopsy at baseline, and then be followed up for 52 weeks.

As well as the biopsies, bloods and urine will be taken at weeks 0, 4, 12, 24, and 52; urine samples taken at weeks 0, 12 and 36; and an additional alea skin tape sample at week 4.

Who Took Part

The registry lists 45 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age \>= 18 years and \<=75 years. Have a documented diagnosis of PsA for at least 6 months AND fulfil the CASPAR criteria (Defined as \>=3 points). Have active PsA defined as \>=3 swollen and \>=3 tender joints (dactylitis counts as a swollen joint). Have a BMI \>= 27 kg/m\^2. Have at least one affected joint amenable to ultrasound-guided synovial biopsy (and must undergo successful synovial biopsy prior to randomisation).

The full record lists 8 inclusion and 73 exclusion criteria; among the exclusions: previous treatment with tirzepatide or any glp-1 receptor agonist; previous treatment with ixekizumab; previous treatment with rituximab.

How the Study Was Run

The set-up was 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.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Tirzepatide study: the psoriasis and psoriatic arthritis participants and staff both knew the treatment.

It started in 2026-03-09 with completion listed for 2028-02.

It ran at 4 sites in United Kingdom (4).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Correlation of molecular changes in biopsies (skin, synovial and adipose) with weight loss (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example Correlation of changes in molecular signatures in the peripheral blood with weight loss.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Tirzepatide in 45 people with psoriasis and psoriatic arthritis.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, Psoriasis and psoriatic arthritis research.

Our Notes on the Compound

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.