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

NCT07830329 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: HS-20094-HS-251092026-526375-39-00
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  From baseline to week 52

Secondary Outcomes (13)

• Percent change in body weight

  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)

  At week 52

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

  From baseline to week 52

• Percent change in weekly average Skin Pain NRS

  From baseline to week 52

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

  From baseline to week 52

Study Arms (2)

Olatorepatide

EXPERIMENTAL

Drug: Olatorepatide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Olatorepatide DRUG

Administered per the protocol

Also known as: HS-20094

Olatorepatide

Placebo DRUG

Administered per the protocol

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa; Abscess; Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Body Weight Changes

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): November 24, 2028
• Study Completion (Estimated): December 22, 2028
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf