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
Lead sponsor
Asset
Olatorepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
0
Recruiting sites
-
Estimated enrollment
300
Study population
Hidradenitis Suppurativa, Obesity / overweight
Eligibility highlights
•BMI ≥27
Primary endpoint
•Total Abscess and inflammatory Nodule (AN) count
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Eligibility criteria
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
Endpoints (14)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointPercent change in body weight
Time frame:From baseline to week 52
percent change from baseline, improvement
Cardiometabolic biomarkers
3 endpointsPercent change in total Abscess and inflammatory Nodule (AN) count
Time frame:From baseline to week 52
percent change from baseline, improvement
Absolute change in high-sensitivity C-Reactive Protein (hsCRP)
Time frame:From baseline up to week 52
change from baseline, improvement
Percent change in hsCRP
Time frame:From baseline up to week 52
percent change from baseline, improvement
Safety / tolerability / PK
2 endpointsOccurrence of Anti-Drug Antibodies (ADAs) to olatorepatide
Time frame:Up to week 56
descriptive
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame:Up to week 56
descriptive
Other (unclassified)
8 endpointsAchieving 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
threshold achievement, improvement
Absolute change in weekly average Skin Pain Numeric Rating Scale (NRS)
Time frame:From baseline to week 52
change from baseline, improvement
Percent change in weekly average Skin Pain NRS
Time frame:From baseline to week 52
percent change from baseline, improvement
Achieving ≥3-point reduction in weekly average Skin Pain NRS
Time frame:From baseline to week 52
change from baseline, improvement
Absolute change in Dermatology Life Quality Index (DLQI)
Time frame:From baseline to week 52
change from baseline, improvement
Achieving minimum clinically important difference (reduction of ≥4 points from baseline score) in the DLQI total score
Time frame:At week 52
threshold achievement, improvement
Concentrations of olatorepatide
Time frame:Up to week 56
concentration, descriptive
Magnitude of ADAs to olatorepatide
Time frame:Up to week 56
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.