Recruiting
Phase 2

Olateroipatide

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07830329

Conditions

Hidradenitis Suppurativa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Olatorepatide

Placebo

Study Details

Brief 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 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

Study ID

NCT07830329

Start date

Oct 29, 2026

Status verified date

Nov, 2026

Completion date

Dec 22, 2028

Anticipated

Primary completion date

Nov 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Diagnosis of HS based on:

1. Documented or reported history of HS for ≥6 months prior to baseline visit
2. Confirmation of HS by the investigator during physical examination at screening
2. HS lesions present in at least 2 distinct anatomic areas as described in the protocol
3. 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)
4. 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
5. Body Mass Index (BMI) ≥27.0 kg/m2 at screening

Key Exclusion Criteria:

1. 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
2. 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
3. Current heart failure classified as being in NYHA Class IV at screening
4. History of chronic pancreatitis or acute pancreatitis
5. Presence of serious Gastrointestinal (GI) disorders (eg, active peptic ulcer, inflammatory bowel disease) at screening
6. 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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Olatorepatide

placebo comparator: Placebo

Interventions

Olatorepatide

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Percent change in total Abscess and inflammatory Nodule (AN) count [ Time Frame: From baseline to week 52 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Equity Medical, LLC

Recruiting

The Bronx, New York, United States, 10455

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • Acne inversa
  • Skin problems
  • Inflammatory skin lesions
  • Painful nodules and abscesses
  • HS inflammatory nodules
  • Abscesses
  • Overweight or obesity
  • Weight loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.