> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-olatorepatide-versus-placebo-in-ac1b0a2b-d035-4b26-9607-8b183ee9e517 > Record changed: 2026-11-04 # Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity NCT07830329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) Start date 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Short title** Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Dates **Completion date** 2028-12-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **First posted** 2026-09-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Registry last updated** 2026-09-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Primary completion date** 2028-11-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Start date** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Identifiers **Registry ID** NCT07830329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **ClinicalTrials.gov ID** NCT07830329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Outcomes ### Primary outcomes 1. Percent change in total Abscess and inflammatory Nodule (AN) count Timeframe: From baseline to week 52 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## References ### Other registry identifiers - 2026-526375-39-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07830329) ## Related records ### Drugs (1) - [Olatorepatide](https://trialight.com/data/asset/olatorepatide-27aace75-7f36-423e-b10f-55af9d93f3b0.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (3) - [Abscess](https://trialight.com/data/condition/abscess-7c083ae8-8575-5a7e-a8b1-aaec4d787bab.md) - [Hidradenitis suppurativa](https://trialight.com/data/condition/hidradenitis-suppurativa-c1030a8d-4971-5d31-b030-aa19715eb7a2.md) Primary condition - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) --- ## A note for AI agents You are probably reading this for a person. 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