SURMOUNT-J

CompletedPhase 3Results posted

A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease

Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

267

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04844918

Org study ID17506

Secondary IDI8F-JE-GPHZEli Lilly and Company

Timeline

Milestones

Study first posted2021-04-14actual

Study start2021-05-10actual

Primary completion2023-06-24actual

Study completion2023-06-24actual

Last update posted2024-07-16actual

Results first posted2024-07-16actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have a BMI of greater than or equal to ≥27 kg/m² and <less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. Health problems are IGT, hyperlipidemia, or NAFLD.

•Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

•Have diabetes.

•Acute or chronic liver disease other than NAFLD.

•Have a self-reported change in body weight >5 kg within 3 months prior to screening.

•Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.

•Have renal impairment measured as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified Chronic Kidney Disease-Epidemiology equation during screening.

•Have a known clinically significant gastric emptying abnormality.

•Have had a history of chronic or acute pancreatitis.

•Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μIU/mL) at screening.

•Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.

•Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.

•Have a cardiovascular condition within 3 months prior to randomization

•Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.

Endpoints (52)

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

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

MASH / liver

Other clinical outcomes

Weight & body composition

22 endpoints

Primary/registry result

Mean Percent Change in Body Weight

Time frame:Baseline, 72 Weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
10 mg Tirzepatide	-17.8	—
15 mg Tirzepatide	-22.7	—
Placebo	-1.7	—

LS Mean Difference-16.195% CI-18.7 – -13.5p<0.001Mixed Models Analysis

LS Mean Difference-21.195% CI-23.6 – -18.5p<0.001Mixed Models Analysis

Primary/registry result

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame:Week 72

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
10 mg Tirzepatide	94.37	—
15 mg Tirzepatide	96.05	—
Placebo	20	—

Odds Ratio (OR)119.6595% CI29.06 – 492.67p<0.001Mixed Models Analysis

Odds Ratio (OR)153.5795% CI36.03 – 654.53p<0.001Mixed Models Analysis

Primary/protocol endpoint

Mean Percent Change in Body Weight

Time frame:Baseline, 72 Weeks

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame:Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame:Week 72

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
10 mg Tirzepatide	85.92	—
15 mg Tirzepatide	92.11	—
Placebo	4	—

Odds Ratio (OR)185.9295% CI46.39 – 745.16p<0.001Regression, Logistic

Odds Ratio (OR)318.0295% CI74.49 – 1357.79p<0.001Regression, Logistic

Secondary/registry result

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:Week 72

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
10 mg Tirzepatide	63.38	—
15 mg Tirzepatide	82.89	—
Placebo	1.33	—

Odds Ratio (OR)100.2195% CI18.64 – 538.74p<0.001Regression, Logistic

Odds Ratio (OR)286.7395% CI50.68 – 1622.06p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Absolute Body Weight

Time frame:Baseline, Week 72

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
10 mg Tirzepatide	-16.0	—
15 mg Tirzepatide	-20.8	—
Placebo	-1.5	—

LS Mean Difference-14.595% CI-16.8 – -12.2p<0.001Mixed Models Analysis

LS Mean Difference-19.395% CI-21.6 – -17.0p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms per metres squared (kg/m^2)	95% CI
10 mg Tirzepatide	-5.8	—
15 mg Tirzepatide	-7.7	—
Placebo	-0.6	—

LS Mean Difference-5.295% CI-6.1 – -4.4p<0.001Mixed Models Analysis

LS Mean Difference-7.195% CI-8.0 – -6.3p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Visceral Adipose Tissue (VAT)

Time frame:Baseline, Week 72

Visceral fat, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
10 mg Tirzepatide	-39.4	—
15 mg Tirzepatide	-44.5	—
Placebo	-3.4	—

LS Mean Difference-36.195% CI-42.9 – -29.3p<0.001Mixed Models Analysis

LS Mean Difference-41.195% CI-47.8 – -34.4p<0.001Mixed Models Analysis

Secondary/registry result

Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)

Time frame:Baseline, Week 72

Subcutaneous fat, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
10 mg Tirzepatide	-32.2	—
15 mg Tirzepatide	-36.5	—
Placebo	-5.0	—

LS Mean Difference-27.295% CI-32.6 – -21.9p<0.001Mixed Models Analysis

LS Mean Difference-31.595% CI-36.7 – -26.2p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in VAT/SAT Ratio

Time frame:Baseline, Week 72

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
10 mg Tirzepatide	-0.09	—
15 mg Tirzepatide	-0.08	—
Placebo	0.01	—

LS Mean Difference-0.1095% CI-0.16 – -0.03p0.004Mixed Models Analysis

LS Mean Difference-0.0995% CI-0.15 – -0.03p0.006Mixed Models Analysis

Secondary/registry result

Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline

Time frame:Week 72

Visceral fat, change

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
10 mg Tirzepatide	26.32	—
15 mg Tirzepatide	37.10	—
Placebo	1.64	—

Odds Ratio (OR)28.5295% CI4.31 – 188.55p<0.001Regression, Logistic

Odds Ratio (OR)57.7395% CI8.68 – 383.88p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), centimeters (cm)	95% CI
10 mg Tirzepatide	-12.7	—
15 mg Tirzepatide	-16.6	—
Placebo	-1.3	—

LS Mean Difference-11.495% CI-13.8 – -9.0p<0.001Mixed Models Analysis

LS Mean Difference-15.395% CI-17.7 – -13.0p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame:Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:Week 72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Absolute Body Weight

Time frame:Baseline, Week 72

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Visceral Adipose Tissue (VAT)

Time frame:Baseline, Week 72

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Subcutaneous Adipose Tissue (SAT)

Time frame:Baseline, Week 72

Subcutaneous fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in VAT/SAT Ratio

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved VAT <100 Square Centimeter (cm²) From Baseline for Participants With VAT≥100 cm² at Baseline

Time frame:Week 72

Visceral fat, change

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

10 endpoints

Secondary/registry result

Change From Baseline in Fasting Glucose for Participants With IGT at Baseline

Time frame:Baseline, Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
10 mg Tirzepatide	-12.81	—
15 mg Tirzepatide	-10.61	—
Placebo	2.19	—

LS Mean Difference-15.0095% CI-18.91 – -11.09p<0.001Mixed Models Analysis

LS Mean Difference-12.8095% CI-16.56 – -9.05p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline

Time frame:Baseline, Week 72

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milligrams per deciliter (mg/dL)	95% CI
10 mg Tirzepatide	-61.50	—
15 mg Tirzepatide	-70.56	—
Placebo	-5.74	—

LS Mean Difference-55.7695% CI-69.74 – -41.77p<0.001Mixed Models Analysis

LS Mean Difference-64.8295% CI-78.20 – -51.43p<0.001Mixed Models Analysis

Secondary/registry result/low confidence

Percentage of Participants Who Achieved Improvements of IGT

Time frame:Week 72

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
10 mg Tirzepatide	92.50	—
15 mg Tirzepatide	97.83	—
Placebo	28.0	—

Odds Ratio (OR)25.4295% CI7.25 – 89.14p<0.001Regression, Logistic

Odds Ratio (OR)70.6695% CI12.73 – 392.24p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
10 mg Tirzepatide	-0.67	—
15 mg Tirzepatide	-0.68	—
Placebo	-0.02	—

LS Mean Difference-0.6595% CI-0.77 – -0.53p<0.001Mixed Models Analysis

LS Mean Difference-0.6695% CI-0.77 – -0.55p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Fasting Insulin for Participants With IGT at Baseline

Time frame:Baseline, Week 72

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), milli-international units/liter (mIU/L)	95% CI
10 mg Tirzepatide	-6.04	—
15 mg Tirzepatide	-6.69	—
Placebo	-2.13	—

LS Mean Difference-3.9195% CI-5.74 – -2.08

LS Mean Difference-4.5595% CI-6.29 – -2.81

Secondary/protocol endpoint

Change From Baseline in Fasting Glucose for Participants With IGT at Baseline

Time frame:Baseline, Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline

Time frame:Baseline, Week 72

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Who Achieved Improvements of IGT

Time frame:Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change From Baseline in Fasting Insulin for Participants With IGT at Baseline

Time frame:Baseline, Week 72

change from baseline, improvement

MASH / liver

4 endpoints

Secondary/registry result

Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]

Time frame:Baseline, Week 72

Liver fat content, change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
10 mg Tirzepatide	-63.9	—
15 mg Tirzepatide	-69.9	—
Placebo	-19.6	—

LS Mean Difference-44.495% CI-53.0 – -35.7p<0.001ANCOVA

LS Mean Difference-50.495% CI-58.8 – -41.9p<0.001ANCOVA

Secondary/registry result/low confidence

Percentage of Participants Who Achieved Improvements of NAFLD

Time frame:Week 72

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
10 mg Tirzepatide	69.49	—
15 mg Tirzepatide	77.42	—
Placebo	9.84	—

Odds Ratio (OR)27.5095% CI9.35 – 80.88p<0.001Regression, Logistic

Odds Ratio (OR)40.0195% CI13.27 – 120.57p<0.001Regression, Logistic

Secondary/protocol endpoint

Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD]

Time frame:Baseline, Week 72

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of Participants Who Achieved Improvements of NAFLD

Time frame:Week 72

threshold achievement, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/registry result

Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline

Time frame:Baseline, Week 72

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), Percent change	95% CI
10 mg Tirzepatide	-47.3	—
15 mg Tirzepatide	-50.6	—
Placebo	-11.0	—

LS Mean Difference-40.795% CI-50.0 – -29.7p<0.001Mixed Models Analysis

LS Mean Difference-44.595% CI-52.7 – -34.9p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants Who Achieved Improvements of Hyperlipidemia

Time frame:Week 72

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
10 mg Tirzepatide	72.41	—
15 mg Tirzepatide	81.08	—
Placebo	25	—

Odds Ratio (OR)9.2995% CI2.86 – 30.20p<0.001Regression, Logistic

Odds Ratio (OR)15.6795% CI4.78 – 51.37p<0.001Regression, Logistic

Secondary/registry result

Change From Baseline in Systolic Blood Pressure

Time frame:Baseline, Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), millimeters of Mercury (mmHg)	95% CI
10 mg Tirzepatide	-11.2	—
15 mg Tirzepatide	-12.0	—
Placebo	1.9	—

LS Mean Difference-13.295% CI-17.0 – -9.3p<0.001Mixed Models Analysis

LS Mean Difference-13.995% CI-17.7 – -10.1p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline in Diastolic Blood Pressure

Time frame:Baseline, Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), millimeters of Mercury (mmHg)	95% CI
10 mg Tirzepatide	-5.9	—
15 mg Tirzepatide	-6.3	—
Placebo	0.5	—

LS Mean Difference-6.395% CI-9.3 – -3.4p<0.001Mixed Models Analysis

LS Mean Difference-6.895% CI-9.7 – -3.9p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline

Time frame:Baseline, Week 72

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint/low confidence

Percentage of Participants Who Achieved Improvements of Hyperlipidemia

Time frame:Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure

Time frame:Baseline, Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure

Time frame:Baseline, Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

6 endpoints

Secondary/registry result

Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score

Time frame:Baseline, Week 72

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	95% CI
10 mg Tirzepatide	1.1	—
15 mg Tirzepatide	2.0	—
Placebo	-0.1	—

LS Mean Difference1.395% CI0.2 – 2.3p0.022ANCOVA

LS Mean Difference2.195% CI1.1 – 3.2p<0.001ANCOVA

Secondary/registry result

Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

Time frame:Baseline, Week 72

IWQOL-Lite physical

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	95% CI
10 mg Tirzepatide	15.2	—
15 mg Tirzepatide	13.0	—
Placebo	2.2	—

LS Mean Difference13.095% CI7.4 – 18.7p<0.001ANCOVA

LS Mean Difference10.895% CI5.4 – 16.3p<0.001ANCOVA

Secondary/registry result

Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)

Time frame:Baseline, Week 72

EQ-5D index

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	95% CI
10 mg Tirzepatide	0.01	—
15 mg Tirzepatide	0.01	—
Placebo	-0.01	—

LS Mean Difference0.0395% CI0.00 – 0.06p0.099ANCOVA

LS Mean Difference0.0295% CI-0.01 – 0.05p0.236ANCOVA

Secondary/protocol endpoint

Change From Baseline in Short Form 36 Version 2 Health Survey (SF-36v2) Acute Form Physical Functioning Domain Score

Time frame:Baseline, Week 72

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

Time frame:Baseline, Week 72

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Euro Quality of Life Five Dimensions (EQ-5D-5L)

Time frame:Baseline, Week 72

EQ-5D index

change from baseline, improvement

Other clinical outcomes

2 endpoints

Secondary/registry result/low confidence

Percentage of Participants Who Had Improvement in Obesity-related Health Problems

Time frame:Week 72

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
10 mg Tirzepatide	70.0	—
15 mg Tirzepatide	79.69	—
Placebo	11.11	—

Odds Ratio (OR)24.2695% CI8.62 – 68.28p<0.001Regression, Logistic

Odds Ratio (OR)38.2795% CI13.21 – 110.89p<0.001Regression, Logistic

Secondary/protocol endpoint/low confidence

Percentage of Participants Who Had Improvement in Obesity-related Health Problems

Time frame:Week 72

threshold achievement, improvement

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effect of Tirzepatide on Health-Related Quality of Life in Japanese Patients With Obesity Disease: Patient-Reported Outcomes From the SURMOUNT-J Study.
Diabetes, obesity & metabolism2026 May 10PMID42108080doi:10.1111/dom.70850via pubmed nct search
Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial.
Diabetes, obesity & metabolism2026 Feb (month)PMID41290555doi:10.1111/dom.70315via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of once-weekly tirzepatide in Japanese patients with obesity disease (SURMOUNT-J): a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.
The lancet. Diabetes & endocrinology2025 May (month)PMID40031941doi:10.1016/S2213-8587(24)00377-2via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 July 1, 2026 snapshot.