RAISE-KT

TerminatedPhase 3Results posted

Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy

A RAndomized trIal Examining the Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy for Patients With Stage 4-5 CKD or Dialysis-dependent ESKD

Lead sponsor

Geisinger Clinic

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Chronic kidney disease, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•eGFR 2-3

Primary endpoint

•Kidney Transplant Eligibility

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 IDNCT04741074

Org study ID2020-1050

Secondary IDUniversal Trial NumberU1111-1249-8833

Timeline

Milestones

Study first posted2021-02-05actual

Study start2021-07-23actual

Primary completion2023-01-31actual

Study completion2023-01-31actual

Last update posted2024-02-09actual

Results first posted2024-02-09actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. - Age ≥ 18 years

2. - BMI 25-45 kg/m2

3. - T2DM

4. - Advanced CKD* (last eGFR <30 ml/min/1.73m2 in EHR or ESKD on dialysis prior to screening) or stage G3B/A2-3 CKD (eGFR 30 to <45 ml/min/1.73m2 with albumin/creatinine ratio >30 mg/g).

5. - Fulfill kidney transplant listing criteria except for one or more of the following reasons (1: uncontrolled diabetes [A1c ≥9%); 2: severe obesity (BMI ≥ 40 kg/m2 or BMI 35-40 kg/m2 with waist circumference >120 cm). See exclusion criteria for general contraindications used for transplant listing used by majority of U.S. transplant centers].

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

7. - Access to a telephone

–The cause of the CKD does not need to be due specifically to diabetes

Exclusion criteria

(General contraindications used for transplant listing used by majority of U.S. transplant centers)

1. - Active malignancy

2. - History of pancreatitis

3. - Active substance abuse

4. - Severe COPD

5. - Pulmonary fibrosis

6. - Symptomatic angina or recent myocardial infarction within 6 months

7. - Severe peripheral vascular disease

8. - Cirrhosis

9. - New York Health Association (NYHA) Class III-IV congestive heart failure

10. - Severe cognitive impairment

11. - Drug addiction

12. - History of non-adherence to therapy

13. - Active infection

14. - Expected life expectancy < 5 years

Additional exclusion criteria

15. - Type 1 diabetes mellitus

16. - History of diabetic ketoacidosis within the last 12 months

17. - Planning on undergoing bariatric surgery in next 9 months.

18. - Pregnant, breast-feeding, or planned pregnancy prior to the end of participation or not using adequate contraceptive measures

19. - Self-reported average consumption of > 21 alcoholic beverages per week or binge drinking

20. - Psychiatric hospitalization in past year

21. - Principal investigator discretion (i.e. concerns about safety, compliance)

22. - Known or suspected allergy to trial medication

23. - Previous participation (i.e. randomized) in this trial

24. - Use of GLP1-RA or pramlintide within 90 days prior to screening

25. - Use of metformin (contraindicated with eGFR < 30 ml/min/1.73m2)

26. - Use of DPP-4 inhibitors within 30 days prior to screening

27. - Personal or family history of medullary thyroid cancer, multiple endocrine neoplasia types 2A and 2B syndrome

28. - Last hemoglobin A1c ≥ 12% or A1c <6% (to avoid risk of hypoglycemia) prior to screening

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

Safety / tolerability / PK

Renal / kidney

Weight & body composition

Cardiometabolic biomarkers

Cardiovascular outcomes

Glycemic / diabetes

MASH / liver

Other clinical outcomes

Cardiovascular outcomes

4 endpoints

Other/protocol endpoint

All-cause Hospitalizations

Time frame:Entire 9-month study period

All-cause hospitalization

event count, event

Other/protocol endpoint/low confidence

Cardiovascular Disease (CVD) Events

Time frame:Entire 9-month study period

event count, event

Other_pre_specified/registry result

All-cause Hospitalizations

Time frame:Entire 9-month study period

All-cause hospitalization

event count, event

Other_pre_specified/registry result/low confidence

Cardiovascular Disease (CVD) Events

Time frame:Entire 9-month study period

event count, event

Weight & body composition

8 endpoints

Secondary/registry result

Change in BMI

Time frame:From baseline to 9 months

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m^2	95% CI
Semaglutide	-2.55	—
Placebo	-.07	—

Secondary/registry result

Change in Waist Circumference

Time frame:From baseline to 9 months

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Semaglutide	-0.52	—
Placebo	3.91	—

Secondary/registry result

Change in Waist-to-hip Ratio

Time frame:From baseline to 9 months

change from baseline, improvement

Posted result

Group	Value (mean), cm/cm	95% CI
Semaglutide	-.00	—
Placebo	0.03	—

Secondary/registry result

Change in Body Fat Percentage

Time frame:From baseline to 9 months

Total fat mass

change from baseline, improvement

Posted result

Group	Value (mean), Body fat percentage	95% CI
Semaglutide	-2.70	—
Placebo	0.13	—

Secondary/protocol endpoint

Change in BMI

Time frame:From baseline to 9 months

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:From baseline to 9 months

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist-to-hip Ratio

Time frame:From baseline to 9 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Fat Percentage

Time frame:From baseline to 9 months

Total fat mass

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/registry result

Change in Hemoglobin A1c (HgbA1c)

Time frame:From baseline to 9 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of glycosylated hemoglobin	95% CI
Semaglutide	-1.10	—
Placebo	0.33	—

Secondary/protocol endpoint

Change in Hemoglobin A1c (HgbA1c)

Time frame:From baseline to 9 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints

Other/protocol endpoint/low confidence

Proportion Experiencing Hepatic Events

Time frame:Entire 9-month study period

event count, event

Other_pre_specified/registry result/low confidence

Proportion Experiencing Hepatic Events

Time frame:Entire 9-month study period

event count, event

Renal / kidney

11 endpoints

Primary/registry result

Kidney Transplant Eligibility

Time frame:Ascertained at the end of 9 months

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide	3	—
Placebo	2	—

Primary/protocol endpoint/low confidence

Kidney Transplant Eligibility

Time frame:Ascertained at the end of 9 months

threshold achievement, improvement

Secondary/registry result

New Activation on the Transplant List

Time frame:Assessed at end of 9 months

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide	3	—
Placebo	0	—

Secondary/registry result

Receipt of Kidney Transplant

Time frame:Assessed at end of 9 months

Kidney-replacement therapy

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide	0	—
Placebo	0	—

Secondary/protocol endpoint

Receipt of Kidney Transplant

Time frame:Assessed at end of 9 months

Kidney-replacement therapy

categorical status, event

Other/protocol endpoint

Change in Albuminuria Among Subset of Participants Without End-stage Kidney Disease

Time frame:Baseline to 9 months

uACR, change

change from baseline, improvement

LOINC 9318-7

Other/protocol endpoint

Change in Estimated Glomerular Filtration (eGFR) Rate Among Subset of Participants Without End-stage Kidney Disease

Time frame:Baseline to 9 months

eGFR, change

change from baseline, improvement

LOINC 98979-8

Other/protocol endpoint

Proportion Experiencing Doubling of Creatinine or End-stage Kidney Disease

Time frame:Entire 9-month study period

Custom renal composite

composite event, event

componentseGFR, change, End-stage renal disease

Other_pre_specified/registry result

Change in Albuminuria Among Subset of Participants Without End-stage Kidney Disease

Time frame:Baseline to 9 months

uACR, change

change from baseline, improvement

LOINC 9318-7

Other_pre_specified/registry result

Change in Estimated Glomerular Filtration (eGFR) Rate Among Subset of Participants Without End-stage Kidney Disease

Time frame:Baseline to 9 months

eGFR, change

change from baseline, improvement

LOINC 98979-8

Other_pre_specified/registry result

Proportion Experiencing Doubling of Creatinine or End-stage Kidney Disease

Time frame:Entire 9-month study period

Custom renal composite

composite event, event

componentseGFR, change, End-stage renal disease

Cardiometabolic biomarkers

8 endpoints

Other/protocol endpoint

Change in Low-Density Lipoprotein (LDL)

Time frame:Baseline to 9 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Other/protocol endpoint

Change in Triglycerides

Time frame:Baseline to 9 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other/protocol endpoint

Change in Systolic Blood Pressure

Time frame:Baseline to 9 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:Baseline to 9 months

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other_pre_specified/registry result

Change in Low-Density Lipoprotein (LDL)

Time frame:Baseline to 9 months

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mg/dL	95% CI
Semaglutide	-6.20	—
Placebo	-6.17	—

Other_pre_specified/registry result

Change in Triglycerides

Time frame:Baseline to 9 months

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other_pre_specified/registry result

Change in Systolic Blood Pressure

Time frame:Baseline to 9 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other_pre_specified/registry result

Change in Diastolic Blood Pressure

Time frame:Baseline to 9 months

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

16 endpoints

Other/protocol endpoint

Proportion Experiencing Death

Time frame:Entire 9-month study period

Death (safety endpoint)

event count, event

SNOMED 419620001

Other/protocol endpoint

Proportion Experiencing Gastrointestinal Disorders

Time frame:Entire 9-month study period

threshold achievement, event

Other/protocol endpoint

Proportion Experiencing Gallbladder Disorders

Time frame:Entire 9-month study period

Gallbladder event

threshold achievement, event

Other/protocol endpoint

Proportion Experiencing Neoplasms

Time frame:Entire 9-month study period

threshold achievement, event

Other/protocol endpoint

Proportion Experiencing Allergic Reactions

Time frame:Entire 9-month study period

threshold achievement, event

Other/protocol endpoint

Proportion Experiencing Injection-site Reactions

Time frame:Entire 9-month study period

threshold achievement, event

Other/protocol endpoint

Proportion Experiencing Hypoglycemia Events

Time frame:Entire 9-month study period

threshold achievement, event

Other/protocol endpoint

Proportion Experiencing Acute Pancreatitis Events

Time frame:Entire 9-month study period

Pancreatitis

event count, event

Other_pre_specified/registry result

Proportion Experiencing Death

Time frame:Entire 9-month study period

Death (safety endpoint)

threshold achievement, event

SNOMED 419620001

Other_pre_specified/registry result

Proportion Experiencing Gastrointestinal Disorders

Time frame:Entire 9-month study period

threshold achievement, event

Other_pre_specified/registry result

Proportion Experiencing Gallbladder Disorders

Time frame:Entire 9-month study period

Gallbladder event

threshold achievement, event

Other_pre_specified/registry result

Proportion Experiencing Neoplasms

Time frame:Entire 9-month study period

threshold achievement, event

Other_pre_specified/registry result

Proportion Experiencing Allergic Reactions

Time frame:Entire 9-month study period

threshold achievement, event

Other_pre_specified/registry result

Proportion Experiencing Injection-site Reactions

Time frame:Entire 9-month study period

threshold achievement, event

Other_pre_specified/registry result

Proportion Experiencing Hypoglycemia Events

Time frame:Entire 9-month study period

Documented hypoglycemia

threshold achievement, event

Other_pre_specified/registry result

Proportion Experiencing Acute Pancreatitis Events

Time frame:Entire 9-month study period

Pancreatitis

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

New Activation on the Transplant List

Time frame:Assessed at end of 9 months

threshold achievement, improvement

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.