Hidradenitis SuppurativaPhase 2NCT07830329
Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity
A Phase 2 study testing Olatorepatide in people with Hidradenitis Suppurativa, run by Regeneron Pharmaceuticals.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Olatorepatide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 22 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of HS based on:
- Documented or reported history of HS for ≥6 months prior to baseline visit
- Confirmation of HS by the investigator during physical examination at screening
- HS lesions present in at least 2 distinct anatomic areas as described in the protocol
- Moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both screening (visit 1) and baseline (visit 2)
- Agree to daily use of over-the-counter topical antiseptics (eg, chlorhexidine gluconate, benzoyl peroxide, or diluted bleach [bath], or alternative antiseptic agents in accordance with local/country guidelines) applied to HS-affected areas as described in the protocol
- Body Mass Index (BMI) ≥27.0 kg/m2 at screening
Who cannot join
- Has a sensitivity (or history of hypersensitivity reactions) to any of the trial interventions, or components thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the trial
- Cardiovascular or cerebrovascular events or procedures within 90 days prior to screening, including myocardial infarction, hospitalization for unstable angina, coronary artery bypass graft, percutaneous coronary intervention as described in the protocol
- Current heart failure classified as being in NYHA Class IV at screening
- History of chronic pancreatitis or acute pancreatitis
- Presence of serious Gastrointestinal (GI) disorders (eg, active peptic ulcer, inflammatory bowel disease) at screening
- Have a previous or current diagnosis of Type 1 Diabetes (T1D) or any other type of diabetes except Type 2 Diabetes (T2D) as described in the protocol
- Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 52-Week Trial to Investigate the Efficacy and Safety of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity
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:
- What side effects olatorepatide might cause
- How well olatorepatide works
- How much olatorepatide is in the blood at different times
- If the body makes antibodies to olatorepatide, which may cause olatorepatide to not work as well
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Olatorepatide, Placebo
- Keywords
- Acne inversa, Skin problems, Inflammatory skin lesions, Painful nodules and abscesses, HS inflammatory nodules, Abscesses, Overweight or obesity, Weight loss
- Medical subject headings
- Hidradenitis Suppurativa, Abscess, Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlatorepatideDrug
Also called HS-20094
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Olatorepatide | Experimental | Not described Receives: Drug: Olatorepatide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total Abscess and inflammatory Nodule (AN) count
Measured: From baseline to week 52
Secondary outcomes (13)
Percent change in body weight
Measured: 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)
Measured: At week 52
Absolute change in weekly average Skin Pain Numeric Rating Scale (NRS)
Measured: From baseline to week 52
Percent change in weekly average Skin Pain NRS
Measured: From baseline to week 52
Achieving ≥3-point reduction in weekly average Skin Pain NRS
Measured: From baseline to week 52
Absolute change in Dermatology Life Quality Index (DLQI)
Measured: From baseline to week 52
Achieving minimum clinically important difference (reduction of ≥4 points from baseline score) in the DLQI total score
Measured: At week 52
Absolute change in high-sensitivity C-Reactive Protein (hsCRP)
Measured: From baseline up to week 52
Percent change in hsCRP
Measured: From baseline up to week 52
Concentrations of olatorepatide
Measured: Up to week 56
Occurrence of Anti-Drug Antibodies (ADAs) to olatorepatide
Measured: Up to week 56
Magnitude of ADAs to olatorepatide
Measured: Up to week 56
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion24 Nov 2028 (estimated)
- Study completion22 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830329
- Sponsor's protocol ID
- HS-20094-HS-25109
- Other IDs
- 2026-526375-39-00
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.