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Not yet recruiting

NCT Number: NCT07830329

Efficacy and Safety of Olatorepatide Versus Placebo 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

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Trial opening soon.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Treatment and study plan

Olatorepatide

Drug

Administered per the protocol

Other names: HS-20094

Placebo

Drug

Administered per the protocol

Primary outcomes

  1. Percent change in total Abscess and inflammatory Nodule (AN) count

    Time frame: From baseline to week 52

Secondary outcomes

  1. Percent change in body weight

    Time frame: From baseline to week 52

  2. 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

  3. Absolute change in weekly average Skin Pain Numeric Rating Scale (NRS)

    Time frame: From baseline to week 52

  4. Percent change in weekly average Skin Pain NRS

    Time frame: From baseline to week 52

  5. Achieving ≥3-point reduction in weekly average Skin Pain NRS

    Time frame: From baseline to week 52

  6. Absolute change in Dermatology Life Quality Index (DLQI)

    Time frame: From baseline to week 52

  7. Achieving minimum clinically important difference (reduction of ≥4 points from baseline score) in the DLQI total score

    Time frame: At week 52

  8. Absolute change in high-sensitivity C-Reactive Protein (hsCRP)

    Time frame: From baseline up to week 52

  9. Percent change in hsCRP

    Time frame: From baseline up to week 52

  10. Concentrations of olatorepatide

    Time frame: Up to week 56

  11. Occurrence of Anti-Drug Antibodies (ADAs) to olatorepatide

    Time frame: Up to week 56

  12. Magnitude of ADAs to olatorepatide

    Time frame: Up to week 56

  13. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to week 56

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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