Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

300 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Regeneron Pharmaceuticals

Study start

Oct 29, 2026 Actual

Primary completion

Nov 24, 2028 Estimated

Study completion

Dec 22, 2028 Estimated

First posted

Sep 21, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts