Trial Outcomes & Findings for Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease (NCT NCT05254418)

Last Updated: 2025-04-20

Results Overview

Sequential MRI will be performed during the run-in phase, at the beginning and end of the dulaglutide treatment and at the end of the observational follow up period. Intermuscular fat will be calculated as the ratio between intermuscular fat and muscle volumes in the mid-thigh region. Changes in intermuscular fat deposition will be calculated. the reported value is the difference between the end of study and baseline values (end of study minus baseline). A negative value will reflect a decrease in IMAT.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

16 weeks

Results posted on

2025-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Dulagutide Arm Patient will receive 1.5 mg injections per week for 12 weeks. dulaglutide injection: All participants will undergo a 4-week run-in phase followed by 12 weeks of treatment (dulaglutide 1.5 mg/wk), followed by 4 weeks of follow up after discontinuing the study medication
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dulagutide Arm Patient will receive 1.5 mg injections per week for 12 weeks. dulaglutide injection: All participants will undergo a 4-week run-in phase followed by 12 weeks of treatment (dulaglutide 1.5 mg/wk), followed by 4 weeks of follow up after discontinuing the study medication
Overall Study Adverse Event	2

Baseline Characteristics

Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dulagutide Arm n=7 Participants Patient will receive 1.5 mg injections per week for 12 weeks. dulaglutide injection: All participants will undergo a 4-week run-in phase followed by 12 weeks of treatment (dulaglutide 1.5 mg/wk), followed by 4 weeks of follow up after discontinuing the study medication
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Age, Continuous	59 years STANDARD_DEVIATION 8 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	7 participants n=93 Participants

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Dulagutide Arm n=7 Participants Patient will receive 1.5 mg injections per week for 12 weeks. dulaglutide injection: All participants will undergo a 4-week run-in phase followed by 12 weeks of treatment (dulaglutide 1.5 mg/wk), followed by 4 weeks of follow up after discontinuing the study medication
Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI).	-0.009 fat/muscle ratio Standard Deviation 0.0526

PRIMARY outcome

Timeframe: 16 weeks

Population: MRS data could not be reported as the required acquisition was not completed. The estimated scan duration exceeded two hours, and there was insufficient time within the reserved scan slot to perform this portion. Additionally, the patients were unable to tolerate the prone position for such an extended period, which ultimately prevented the collection of data necessary for MRS analysis.

Sequential 31P-MRS, a gold standard technique for muscle mitochondrial function assessment, will be performed during the run-in phase, at the beginning and end of the dulaglutide treatment and at the end of the observational follow up period. Changes in phosphocreatine recovery time constant will be assessed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 16 weeks

Systemic physical performance battery test will be performed at the beginning and end of the dulaglutide treatment period. Changes will be assessed. The total score that will be reported is calculated by adding scores obtained from Balance test, Gait speed test and Chair stand test scores. The score for the primary outcome will be the difference between baseline and end of study. The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three or four classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance); or four classes: 0-3 points (disability/very poor performance), 4-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance)

Outcome measures

Outcome measures
Measure	Dulagutide Arm n=7 Participants Patient will receive 1.5 mg injections per week for 12 weeks. dulaglutide injection: All participants will undergo a 4-week run-in phase followed by 12 weeks of treatment (dulaglutide 1.5 mg/wk), followed by 4 weeks of follow up after discontinuing the study medication
Changes in Physical Performance as Assessed by Systemic Physical Performance Battery Test	0 score on a scale Standard Deviation 2.24

PRIMARY outcome

Timeframe: 16 weeks

An AE will be defined as any undesirable medical event occurring to a subject in a clinical trial, whether it is related to the study agent. All adverse events will be graded as follows: 0 = No adverse events or within normal limits; 1 = Mild-did not require treatment; 2 = Moderate resolved with treatment; 3 = Severe-required professional medical attention; 4 = Life-threatening or disabling; 5 = Death.

Outcome measures

Outcome measures
Measure	Dulagutide Arm n=7 Participants Patient will receive 1.5 mg injections per week for 12 weeks. dulaglutide injection: All participants will undergo a 4-week run-in phase followed by 12 weeks of treatment (dulaglutide 1.5 mg/wk), followed by 4 weeks of follow up after discontinuing the study medication
Safety and Feasibility of Dulaglutide Treatment as Evaluated by Subject Interview, Continuous Glucose Monitoring, Adverse Events (AE), Laboratory Tests, Vital Signs, ECG & Allergic/Hypersensitivity Reactions.	2 Participants

Adverse Events

Run-in-Period

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dulagutide Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Run-in-Period n=7 participants at risk Patient will undergo a 4-week run in phase before starting the intervention.	Dulagutide Arm n=7 participants at risk Patient will receive 1.5 mg injections per week for 12 weeks. dulaglutide injection: The intervention will start at the beginning of the Treatment Phase and will continue for12 weeks of treatment.	Follow-up n=7 participants at risk Patients will undergo a 4 week follow up phase after the intervention and before ending the study.
Gastrointestinal disorders nausea	0.00% 0/7 • 16 weeks: 12 weeks while the patient is on the medication and 4 weeks of follow up after the study is completed. There is only one arm in this study.	14.3% 1/7 • Number of events 1 • 16 weeks: 12 weeks while the patient is on the medication and 4 weeks of follow up after the study is completed. There is only one arm in this study.	0.00% 0/7 • 16 weeks: 12 weeks while the patient is on the medication and 4 weeks of follow up after the study is completed. There is only one arm in this study.
Skin and subcutaneous tissue disorders local injection site erythema	0.00% 0/7 • 16 weeks: 12 weeks while the patient is on the medication and 4 weeks of follow up after the study is completed. There is only one arm in this study.	14.3% 1/7 • Number of events 1 • 16 weeks: 12 weeks while the patient is on the medication and 4 weeks of follow up after the study is completed. There is only one arm in this study.	0.00% 0/7 • 16 weeks: 12 weeks while the patient is on the medication and 4 weeks of follow up after the study is completed. There is only one arm in this study.

Additional Information

Dr. Talat Alp Ikizler

Vanderbilt University Medical Center

Phone: 6159366646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place