Small open-label study reports 80 percent response to tirzepatide in hidradenitis suppurativa
A small uncontrolled study suggests tirzepatide may ease a painful skin condition, but its design cannot show the drug caused the improvement.
A 20-person study found that 16 adults with moderate-to-severe hidradenitis suppurativa (80 percent) met the standard response measure after 24 weeks of tirzepatide, according to results published online November 25, 2025, in the Journal of Drugs in Dermatology [1]. The study was open-label and single-arm, with no control group and no blinding, so it cannot show that the drug caused the improvement [1].
What the study did
Participants were adults with hidradenitis suppurativa rated 3 or higher on the Physician's Global Assessment and a body mass index of at least 27 [1]. All 20 received once-weekly tirzepatide for 24 weeks, with the dose raised to the highest level each person tolerated, followed by an 8-week washout period with no drug [1].
The primary endpoint was HiSCR — Hidradenitis Suppurativa Clinical Response, the standard response measure in this disease — at week 24. Sixteen of 20 participants (80.0 percent) reached it, a result the authors report with a P value below 0.00001 [1]. Analyses used an intention-to-treat approach, meaning all enrolled participants were counted [1].
Secondary measures were changes in the Physician's Global Assessment, the Dermatology Life Quality Index, a pain visual analog scale, and the Hospital Anxiety and Depression Scale [1]. The authors report improvements in the quality-of-life index, pain scores and the physician assessment, with some benefits persisting through week 32, the end of the washout [1]. No specific result for the anxiety and depression scale appears in the published abstract. The authors describe treatment as well tolerated, with high adherence and favorable metabolic effects [1].
Limits the authors name
The authors list the single-center, open-label design and modest sample size as limitations, and write that larger randomized trials are needed to confirm efficacy, durability and safety [1]. Because every participant received the drug and knew it, and there was no comparison group, the study cannot separate a drug effect from other reasons a person might improve.
One of the five listed authors has an affiliation with Eli Lilly and Company [1]. The article does not state who funded the study.
The trial is registered on ClinicalTrials.gov as NCT06301256, titled "Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis Suppurativa" [2]. Enrollment targets and start or completion dates for any larger follow-up trial have not been reported.
Why it matters for patients
Hidradenitis suppurativa causes deep, painful lumps, mainly in skin folds, and is linked to obesity, abnormal cholesterol and type 2 diabetes [1]. The authors note that current treatments — including adalimumab, secukinumab, bimekizumab, and oral and topical antibiotics — give variable benefit and do not target the metabolic and inflammatory factors they believe help drive the disease [1].
For patients, an 80 percent response rate in a small, uncontrolled study is a signal worth following, not a settled result. The authors call the work proof of concept; whether tirzepatide helps HS through weight loss, through direct anti-inflammatory effects, or both has not been established [1].
All participants had a BMI of at least 27, so these results do not address whether the drug affects HS in people below that threshold. The article reports no regulatory approval of tirzepatide for hidradenitis suppurativa, and no data here on whether insurers would cover it for that use.
What happens next
The authors call for larger randomized trials to confirm the findings [1]. No sponsor, size or start date for such a trial has been disclosed. The report covers results through week 32; data on how long any benefit lasts beyond that have not been reported [1].
Sources
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