NCT07830329Not yet recruitingPhase 2
Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity
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 · Last updated 21 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 15 Sept 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 24 Nov 2028
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Obesity
- NCT number
- NCT07830329
- EU CT number
- 2026-526375-39-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- From 30 Oct 2026 to the primary completion date, 24 Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.