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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07830329
- Acronym / sponsor ID
- HS-20094-HS-25109
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Acne inversa, Skin problems, Inflammatory skin lesions, Painful nodules and abscesses, HS inflammatory nodules, Abscesses, Overweight or obesity, Weight loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 24 Nov 2028 (estimated)
- Study completion
- 22 Dec 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olatorepatide | Experimental | Drug: Olatorepatide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of HS based on:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlatorepatideAlso: HS-20094Administered per the protocol | Drug | Olatorepatide |
| PlaceboAdministered per the protocol | Drug | Placebo |
Primary outcome
Percent change in total Abscess and inflammatory Nodule (AN) count
Time frame: From baseline to week 52
13 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olatorepatide in people with Hidradenitis Suppurativa, run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in total Abscess and inflammatory Nodule (AN) count (time frame: From baseline to week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.