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Not 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

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

NCT IDNCT07830329
Org study IDHS-20094-HS-25109
Secondary ID2026-526375-39-00

Timeline

Milestones

Study first posted2026-09-21actual
Last update posted2026-09-21actual
Study start2026-10-30estimated
Primary completion2028-11-24estimated
Study completion2028-12-22estimated

Assets

Investigational agents

Who this study enrolls

Hidradenitis SuppurativaObesity / overweight

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
8
Cardiometabolic biomarkers
3
Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Percent change in body weight

Time frame:From baseline to week 52

percent change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Primary/protocol endpoint

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

Time frame:From baseline to week 52

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From baseline up to week 52

change from baseline, improvement

Secondary/protocol endpoint

Percent change in hsCRP

Time frame:From baseline up to week 52

percent change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Occurrence of Anti-Drug Antibodies (ADAs) to olatorepatide

Time frame:Up to week 56

descriptive

Secondary/protocol endpoint

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time frame:Up to week 56

descriptive

Other (unclassified)

8 endpoints
Secondary/protocol endpoint/low confidence

Achieving 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

Secondary/protocol endpoint/low confidence

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

Time frame:From baseline to week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percent change in weekly average Skin Pain NRS

Time frame:From baseline to week 52

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:From baseline to week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Absolute change in Dermatology Life Quality Index (DLQI)

Time frame:From baseline to week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Secondary/protocol endpoint/low confidence

Concentrations of olatorepatide

Time frame:Up to week 56

concentration, descriptive

Secondary/protocol endpoint/low confidence

Magnitude of ADAs to olatorepatide

Time frame:Up to week 56

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.