A Phase 2 interventional study of Olatorepatide and Placebo in Hidradenitis Suppurativa, sponsored by Regeneron Pharmaceuticals. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment
This study will test an experimental Regeneron drug called olatorepatide ("study drug") to see if it can help treat Hidradenitis Suppurativa (HS).
In this study, olatorepatide is being tested in people with HS and living with overweight or obesity to see if it helps improve their HS symptoms and quality of life and helps support weight loss.
The study is looking at:
284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.
This study's planned enrollment of 300 is above the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Diagnosis of HS based on:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Olatorepatide
Drug: Placebo
Administered per the protocol
Also known as: HS-20094
Administered per the protocol
Percent change in total Abscess and inflammatory Nodule (AN) count
Time frame: From baseline to week 52
Percent change in body weight
Time frame: From baseline to week 52
Achieving HiSCR50 (≥50% reduction from baseline in total AN counts with no increase in abscess count and no increase in draining tunnel count)
Time frame: At week 52
Absolute change in weekly average Skin Pain Numeric Rating Scale (NRS)
Time frame: From baseline to week 52
Percent change in weekly average Skin Pain NRS
Time frame: From baseline to week 52
Achieving ≥3-point reduction in weekly average Skin Pain NRS
Time frame: From baseline to week 52
Absolute change in Dermatology Life Quality Index (DLQI)
Time frame: From baseline to week 52
Achieving minimum clinically important difference (reduction of ≥4 points from baseline score) in the DLQI total score
Time frame: At week 52
Absolute change in high-sensitivity C-Reactive Protein (hsCRP)
Time frame: From baseline up to week 52
Percent change in hsCRP
Time frame: From baseline up to week 52
Concentrations of olatorepatide
Time frame: Up to week 56
Occurrence of Anti-Drug Antibodies (ADAs) to olatorepatide
Time frame: Up to week 56
Magnitude of ADAs to olatorepatide
Time frame: Up to week 56
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to week 56
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Nov 2028, 24 months after the start.
Of 44 industry-sponsored phase 2 interventional studies under Hidradenitis Suppurativa, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 20. This study's planned 24 months is above that.
Counting every sponsor, half of 54 studies reached it within 15 months; a quarter within 11 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Olatorepatide