← Trials/Trial dossier/NCT02911818

MODEL

CompletedPhase 4Results posted

Lifestyle Modification and Liraglutide

Combining Lifestyle Modification and Liraglutide to Improve Weight Loss and Health Outcomes

Lead sponsor

University of Pennsylvania

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

150

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-55

Primary endpoint

•Body weight, % change

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 IDNCT02911818

Org study ID824806

Timeline

Milestones

Study first posted2016-09-22estimated

Last update posted2019-05-07actual

Results first posted2019-05-07actual

Study start2016-09actual (month precision)

Primary completion2018-11actual (month precision)

Study completion2018-12actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age21 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Participants must have a BMI ≥ 30 and ≤ 55 kg/m²

2. Age ≥ 21 years and ≤ 70 years

3. Eligible female patients will be:

–non-pregnant, evidenced by a negative urine dipstick pregnancy test

–non-lactating

–surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study

4. Ability to provide informed consent before any trial-related activities

5. Participants must:

–have a primary care provider (PCP) who is responsible for providing routine care

–have a reliable telephone service with which to communicate with study staff

–understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent

–plan to remain in the Philadelphia area for the next 18 months

Exclusion criteria

1. Pregnant or nursing, or plans to become pregnant in the next 18 months, or not using adequate contraceptive measures

2. Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2

3. Uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 100 mm Hg)

4. Type 1 diabetes

5. Type 2 diabetes

6. A fasting glucose ≥ 126 mg/dl (on second assessment after first elevated value)

7. Recent history of cardiovascular disease (e.g., myocardial infarction or stroke within the past 6 months), congestive heart failure, or heart block greater than first degree

8. Clinically significant hepatic or renal disease

9. Thyroid disease, not controlled

10. History of malignancy (except for non-melanoma skin cancer) in past 5 years

11. Current major depressive episode, active suicidal ideation, or history of suicide attempts

12. Psychiatric hospitalization within the past 6 months

13. Self-reported alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week)

14. Use in past 3 months of medications known to induce significant weight loss (i.e., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)

15. Loss of ≥ 10 lb of body weight within the past 3 months

16. History of (or plans for) bariatric surgery

17. Inability to walk 5 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)

18. Known or suspected allergy to trial medication(s), excipients, or related products

19. Hypersensitivity to liraglutide or any product components

20. The receipt of any investigational drug within 6 months prior to this trial

21. Previous participation in this trial (e.g., randomized and failed to participate)

22. History of pancreatitis

23. Subjects will be included/excluded according to the latest updated US PI.

12-Week Extension Trial:

Inclusion Criteria

Inclusion criteria are those described for the original 1-year trial (enumerated above). The principal exception from these criteria is that participants will only be required to have a BMI > 27 kg/m2, with or without co-morbidities, to be eligible to participate in the extension study. All participants will have met BMI inclusion criteria when they initiated the use of liraglutide and now will use it, potentially with phentermine 15 mg/d, to facilitate to the maintenance of lost weight. (Liraglutide is approved for chronic weight management, including following successful weight loss.) We do not wish to enroll participants with a BMI < 27 kg/m2 because of the possibility that they could reduce substantially below a BMI of 24.9 kg/m2, the upper limit of "normal" weight.

Exclusion Criteria:

Exclusion criteria will include those listed in the original protocol, including those specific to the use of liraglutide 3.0 mg/d (e.g., family history of medullary thyroid cancer).

Additional exclusion criteria added to the 12-week extension study are specific to the use of phentermine 15 mg/d. They include:

1. Use of monoamine oxidase inhibitors in the past 2 weeks

2. Glaucoma

3. Presence or history of marked agitation

4. History of drug abuse

5. Known hypersensitivity to sympathomimetic amines

6. Current use of selective serotonin re-uptake inhibitors (e.g., fluoxetine, sertraline, etc)

7. Current use of any other weight loss medications (besides liraglutide 3.0 mg/d)

8. History of coronary artery disease

Endpoints (68)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

8 endpoints

Primary/registry result

Percent Change in Baseline Weight

Time frame:Randomization and 52 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
CMS-Alone	-6.1	—
CMS-Liraglutide	-11.5	—
Multi-Component Intervention	-11.8	—

Primary/registry result

Extension Study Primary Outcome: Percent Change in Re-randomization Weight

Time frame:Re-randomization and 12 weeks

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
12-Week Extension Study: Phentermine Group	-1.6	—
12-Week Extension Study: Placebo Group	-0.1	—

Primary/protocol endpoint

Percent Change in Baseline Weight

Time frame:Randomization and 52 weeks

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Extension Study Primary Outcome: Percent Change in Re-randomization Weight

Time frame:Re-randomization and 12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Change in Waist Circumference

Time frame:Randomization and 52 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
CMS-Alone	-6.5	—
CMS-Liraglutide	-11.1	—
Multi-Component Intervention	-12.6	—

Secondary/registry result

Extension Study Secondary Outcome: Change in Waist Circumference

Time frame:Re-randomization and 12 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
12-Week Extension Study: Placebo Group	-0.6	—
12-Week Extension Study: Phentermine Group	-0.4	—

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Randomization and 52 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in Waist Circumference

Time frame:Re-randomization and 12 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

16 endpoints

Secondary/registry result

Change in Fasting Glucose

Time frame:Randomization and 52 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
CMS-Alone	0.01	—
CMS-Liraglutide	-5.2	—
Multi-Component Intervention	-5.7	—

Secondary/registry result

Change in HbA1c

Time frame:Randomization and 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage	95% CI
CMS-Alone	-0.3	—
CMS-Liraglutide	-0.5	—
Multi-Component Intervention	-0.6	—

Secondary/registry result/low confidence

Change in Fasting Insulin

Time frame:Randomization and 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), uIU/mL	95% CI
CMS-Alone	-1.5	—
CMS-Liraglutide	-1.1	—
Multi-Component Intervention	-1.5	—

Secondary/registry result

Change in HOMA-IR

Time frame:Randomization and 52 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL*µIU/mL/405	95% CI
CMS-Alone	-0.4	—
CMS-Liraglutide	-0.3	—
Multi-Component Intervention	-0.4	—

Secondary/registry result

Extension Study Secondary Outcome: Change in Fasting Glucose

Time frame:Re-randomization and 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
12-Week Extension Study: Placebo Group	1.4	—
12-Week Extension Study: Phentermine Group	6.3	—

Secondary/registry result

Extension Study Secondary Outcome: Change in HbA1c

Time frame:Re-randomization and 12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage	95% CI
12-Week Extension Study: Placebo Group	0.0	—
12-Week Extension Study: Phentermine Group	0.0	—

Secondary/registry result

Extension Study Secondary Outcome: Change in Fasting Insulin

Time frame:Re-randomization and 12 weeks

change from baseline, improvement

Posted result

Group	Value (mean), uIU/mL	95% CI
12-Week Extension Study: Placebo Group	0.2	—
12-Week Extension Study: Phentermine Group	0.5	—

Secondary/registry result

Extension Study Secondary Outcome: Change in HOMA-IR

Time frame:Re-randomization and 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL*µIU/mL/405	95% CI
12-Week Extension Study: Placebo Group	0.1	—
12-Week Extension Study: Phentermine Group	0.3	—

Secondary/protocol endpoint

Change in Fasting Glucose

Time frame:Randomization and 52 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in HbA1c

Time frame:Randomization and 52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Insulin

Time frame:Randomization and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in HOMA-IR

Time frame:Randomization and 52 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in Fasting Glucose

Time frame:Re-randomization and 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in HbA1c

Time frame:Re-randomization and 12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Extension Study Secondary Outcome: Change in Fasting Insulin

Time frame:Re-randomization and 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in HOMA-IR

Time frame:Re-randomization and 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

32 endpoints

Secondary/registry result

Change in Systolic Blood Pressure

Time frame:Randomization and 52 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mm Hg	95% CI
CMS-Alone	-14.1	—
CMS-Liraglutide	-13.3	—
Multi-Component Intervention	-15.3	—

Secondary/registry result

Change in Diastolic Blood Pressure

Time frame:Randomization and 52 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mm Hg	95% CI
CMS-Alone	-3.0	—
CMS-Liraglutide	-2.9	—
Multi-Component Intervention	-3.5	—

Secondary/registry result

Change in Heart Rate

Time frame:Randomization and 52 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
CMS-Alone	-7.4	—
CMS-Liraglutide	-5.3	—
Multi-Component Intervention	9.7	—

Secondary/registry result

Change in Total Cholesterol

Time frame:Randomization and 52 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mg/dL	95% CI
CMS-Alone	-7.0	—
CMS-Liraglutide	-9.7	—
Multi-Component Intervention	-10.0	—

Secondary/registry result

Change in LDL Cholesterol

Time frame:Randomization and 52 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mg/dL	95% CI
CMS-Alone	-3.3	—
CMS-Liraglutide	-9.6	—
Multi-Component Intervention	-9.4	—

Secondary/registry result

Change in HDL Cholesterol

Time frame:Randomization and 52 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mg/dL	95% CI
CMS-Alone	-1.3	—
CMS-Liraglutide	3.0	—
Multi-Component Intervention	2.0	—

Secondary/registry result

Change in Triglycerides

Time frame:Randomization and 52 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mg/dL	95% CI
CMS-Alone	-16.3	—
CMS-Liraglutide	-21.3	—
Multi-Component Intervention	-14.4	—

Secondary/registry result

Change in C Reactive Protein

Time frame:Randomization and 52 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (mean), mg/L	95% CI
CMS-Alone	-0.4	—
CMS-Liraglutide	-2.0	—
Multi-Component Intervention	-3.0	—

Secondary/registry result

Extension Study Secondary Outcome: Change in Systolic Blood Pressure

Time frame:Re-randomization and 12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mm Hg	95% CI
12-Week Extension Study: Placebo Group	1.2	—
12-Week Extension Study: Phentermine Group	2.0	—

Secondary/registry result

Extension Study Secondary Outcome: Change in Diastolic Blood Pressure

Time frame:Re-randomization and 12 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mm Hg	95% CI
12-Week Extension Study: Phentermine Group	1.3	—
12-Week Extension Study: Placebo Group	0.2	—

Secondary/registry result

Extension Study Secondary Outcome: Change in Heart Rate

Time frame:Re-randomization and 12 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
12-Week Extension Study: Placebo Group	0	—
12-Week Extension Study: Phentermine Group	2.1	—

Secondary/registry result

Extension Study Secondary Outcome: Change in Total Cholesterol

Time frame:Re-randomization and 12 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mg/dL	95% CI
12-Week Extension Study: Placebo Group	3.4	—
12-Week Extension Study: Phentermine Group	0.4	—

Secondary/registry result

Extension Study Secondary Outcome: Change in LDL Cholesterol

Time frame:Re-randomization and 12 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mg/dL	95% CI
12-Week Extension Study: Placebo Group	2.3	—
12-Week Extension Study: Phentermine Group	-2.4	—

Secondary/registry result

Extension Study Secondary Outcome: Change in HDL Cholesterol

Time frame:Re-randomization and 12 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mg/dL	95% CI
12-Week Extension Study: Placebo Group	0.6	—
12-Week Extension Study: Phentermine Group	2.0	—

Secondary/registry result

Extension Study Secondary Outcome: Change in Triglycerides

Time frame:Re-randomization and 12 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mg/dL	95% CI
12-Week Extension Study: Placebo Group	4.1	—
12-Week Extension Study: Phentermine Group	6.6	—

Secondary/registry result

Extension Study Secondary Outcome: Change in c-Reactive Protein

Time frame:Re-randomization and 12 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (mean), mg/L	95% CI
12-Week Extension Study: Placebo Group	-0.8	—
12-Week Extension Study: Phentermine Group	-0.6	—

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:Randomization and 52 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:Randomization and 52 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Heart Rate

Time frame:Randomization and 52 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:Randomization and 52 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in LDL Cholesterol

Time frame:Randomization and 52 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in HDL Cholesterol

Time frame:Randomization and 52 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Triglycerides

Time frame:Randomization and 52 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in C Reactive Protein

Time frame:Randomization and 52 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in Systolic Blood Pressure

Time frame:Re-randomization and 12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in Diastolic Blood Pressure

Time frame:Re-randomization and 12 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in Heart Rate

Time frame:Re-randomization and 12 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in Total Cholesterol

Time frame:Re-randomization and 12 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in LDL Cholesterol

Time frame:Re-randomization and 12 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in HDL Cholesterol

Time frame:Re-randomization and 12 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in Triglycerides

Time frame:Re-randomization and 12 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Extension Study Secondary Outcome: Change in c-Reactive Protein

Time frame:Re-randomization and 12 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

12 endpoints

Secondary/registry result

Change in 36-Item Short Form Survey (SF-36) - Physical Component Summary

Time frame:Randomization and 52 weeks

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), T scores	95% CI
CMS-Alone	4.4	—
CMS-Liraglutide	2.1	—
Multi-Component Intervention	3.4	—

Secondary/registry result

Change 36-Item Short Form Survey (SF-36) - Mental Component Summary

Time frame:Randomization and 52 weeks

SF-36 mental

change from baseline, improvement

Posted result

Group	Value (mean), T scores	95% CI
CMS-Alone	0.8	—
CMS-Liraglutide	4.5	—
Multi-Component Intervention	6.4	—

Secondary/registry result

Change in Patient Health Questionnaire (PHQ-9)

Time frame:Randomization and 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	95% CI
CMS-Alone	-1.8	—
CMS-Liraglutide	-1.9	—
Multi-Component Intervention	-1.5	—

Secondary/registry result

Extension Study Secondary Outcome: SF-36 - Physical Health Component

Time frame:Re-randomization and 12 weeks

SF-36 physical

descriptive, improvement

Posted result

Group	Value (mean), T scores	95% CI
12-Week Extension Study: Placebo Group	0.3	—
12-Week Extension Study: Phentermine Group	-1.2	—

Secondary/registry result

Extension Study Secondary Outcome: SF-36 - Mental Health Component

Time frame:Re-randomization and 12 weeks

SF-36 mental

descriptive, improvement

Posted result

Group	Value (mean), T scores	95% CI
12-Week Extension Study: Placebo Group	-0.1	—
12-Week Extension Study: Phentermine Group	0.2	—

Secondary/registry result

Extension Study Secondary Outcome: Patient Health Questionnaire (PHQ-9)

Time frame:Re-randomization and 12 weeks

descriptive, improvement

Posted result

Group	Value (mean), score on a scale	95% CI
12-Week Extension Study: Placebo Group	0.2	—
12-Week Extension Study: Phentermine Group	0.0	—

Secondary/protocol endpoint

Change in 36-Item Short Form Survey (SF-36) - Physical Component Summary

Time frame:Randomization and 52 weeks

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change 36-Item Short Form Survey (SF-36) - Mental Component Summary

Time frame:Randomization and 52 weeks

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in Patient Health Questionnaire (PHQ-9)

Time frame:Randomization and 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Extension Study Secondary Outcome: SF-36 - Physical Health Component

Time frame:Re-randomization and 12 weeks

SF-36 physical

descriptive, improvement

Secondary/protocol endpoint

Extension Study Secondary Outcome: SF-36 - Mental Health Component

Time frame:Re-randomization and 12 weeks

SF-36 mental

descriptive, improvement

Secondary/protocol endpoint

Extension Study Secondary Outcome: Patient Health Questionnaire (PHQ-9)

Time frame:Re-randomization and 12 weeks

change from baseline, 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

Effects of liraglutide on appetite, food preoccupation, and food liking: results of a randomized controlled trial.
International journal of obesity (2005)2020 Feb (month)PMID30926955doi:10.1038/s41366-019-0348-6via clinicaltrials gov reference derived + pubmed nct search
Effects of liraglutide plus phentermine in adults with obesity following 1 year of treatment by liraglutide alone: A randomized placebo-controlled pilot trial.
Metabolism: clinical and experimental2019 Jul (month)PMID30902750doi:10.1016/j.metabol.2019.03.005via clinicaltrials gov reference derived + pubmed nct search
Intensive Behavioral Therapy for Obesity Combined with Liraglutide 3.0 mg: A Randomized Controlled Trial.
Obesity (Silver Spring, Md.)2019 Jan (month)PMID30421856doi:10.1002/oby.22359via 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.