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

NCT07830329
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Not yet recruiting
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Participants
300
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2026-10-30
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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
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Short title
Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity
clinicaltrials.gov
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2028-12-22
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First posted
2026-09-21
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Registry last updated
2026-09-21
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Primary completion date
2028-11-24
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Start date
2026-10-30
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Participants
300
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Participant count basis
Estimated
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Planned participants
300
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Protocol amendments
0
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07830329
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ClinicalTrials.gov ID
NCT07830329
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: From baseline to week 52

  1. Percent change in body weight

    Timeframe: 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)

    Timeframe: At week 52

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

    Timeframe: From baseline to week 52

  4. Percent change in weekly average Skin Pain NRS

    Timeframe: From baseline to week 52

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

    Timeframe: From baseline to week 52

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

    Timeframe: From baseline to week 52

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

    Timeframe: At week 52

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

    Timeframe: From baseline up to week 52

  9. Percent change in hsCRP

    Timeframe: From baseline up to week 52

  10. Concentrations of olatorepatide

    Timeframe: Up to week 56

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

    Timeframe: Up to week 56

  12. Magnitude of ADAs to olatorepatide

    Timeframe: Up to week 56

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

    Timeframe: Up to week 56

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

Sources for eligibility
clinicaltrials.gov

Other registry identifiers

  • 2026-526375-39-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)