Trial Outcomes & Findings for Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy (NCT NCT04741074)

NCT ID: NCT04741074

Last Updated: 2024-02-09

Results Overview

Proportion either listed for kidney transplant at 9 months or meeting the following kidney transplant candidacy criteria for A1c (\<9%) and obesity (BMI \<35 kg/m2 or BMI 35-40 kg/m2 with waist circumference \<120 cm)

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 15 participants
• Primary outcome timeframe: Ascertained at the end of 9 months
• Results posted on: 2024-02-09

Participant Flow

Participant milestones

Measure	Semaglutide This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.	Placebo This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.
Overall Study STARTED	7	8
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Semaglutide This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.	Placebo This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.
Overall Study Withdrawal by Subject	1	1
Overall Study Study terminated prematurely	1	0

Baseline Characteristics

Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy

Baseline characteristics by cohort

Measure	Semaglutide n=7 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.	Placebo n=8 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Total n=15 Participants Total of all reporting groups
Age, Continuous Age	62.29 years STANDARD_DEVIATION 3.00 • n=5 Participants	59.13 years STANDARD_DEVIATION 14.88 • n=7 Participants	60.60 years STANDARD_DEVIATION 11.84 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Hemoglobin A1c	6.8 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.38 • n=5 Participants	6.70 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.50 • n=7 Participants	6.75 Percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.31 • n=5 Participants
BMI	39.7 kg/m^2 STANDARD_DEVIATION 5.37 • n=5 Participants	40.20 kg/m^2 STANDARD_DEVIATION 4.12 • n=7 Participants	39.95 kg/m^2 STANDARD_DEVIATION 4.57 • n=5 Participants
Waist circumference	132.37 cm STANDARD_DEVIATION 5.99 • n=5 Participants	124.20 cm STANDARD_DEVIATION 9.77 • n=7 Participants	128.01 cm STANDARD_DEVIATION 13.16 • n=5 Participants

PRIMARY outcome

Timeframe: Ascertained at the end of 9 months

Proportion either listed for kidney transplant at 9 months or meeting the following kidney transplant candidacy criteria for A1c (<9%) and obesity (BMI <35 kg/m2 or BMI 35-40 kg/m2 with waist circumference <120 cm)

Outcome measures

Measure	Placebo n=7 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Semaglutide n=5 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Kidney Transplant Eligibility	2 Participants	3 Participants

SECONDARY outcome

Timeframe: From baseline to 9 months

HgbA1c will be collected using routine procedures and measured on the same day at the central Geisinger laboratory by Turbidimetric inhibition immunoassay.

Outcome measures

Measure	Placebo n=7 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Semaglutide n=5 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Change in Hemoglobin A1c (HgbA1c)	0.33 Percentage of glycosylated hemoglobin Standard Deviation 0.78	-1.10 Percentage of glycosylated hemoglobin Standard Deviation 1.03

SECONDARY outcome

Timeframe: From baseline to 9 months

Weight will be measured at each study visit in light clothing without shoes by trained, certified staff using a calibrated, digital scale. Scales will be calibrated annually. Height will be measured at the initial study visit to the nearest 0.1 cm using a calibrated, wall-mounted stadiometer without shoes on a firm, level surface, with head in the horizontal plane.

Outcome measures

Measure	Placebo n=7 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Semaglutide n=5 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Change in BMI	-.07 kg/m^2 Standard Deviation 2.70	-2.55 kg/m^2 Standard Deviation 4.25

SECONDARY outcome

Timeframe: From baseline to 9 months

Waist circumference will be measured at each study visit to the nearest 0.1 cm using a Gulick II tape measure.

Outcome measures

Measure	Placebo n=7 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Semaglutide n=5 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Change in Waist Circumference	3.91 cm Standard Deviation 6.32	-0.52 cm Standard Deviation 14.38

SECONDARY outcome

Timeframe: From baseline to 9 months

Hip circumference will also be measured to the nearest 0.1 cm using a Gulick II tape measure, and waist-to-hip ratio will be calculated.

Outcome measures

Measure	Placebo n=7 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Semaglutide n=5 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Change in Waist-to-hip Ratio	0.03 cm/cm Standard Deviation 0.05	-.00 cm/cm Standard Deviation 0.11

SECONDARY outcome

Timeframe: From baseline to 9 months

Measured using bioelectrical impedance analysis

Outcome measures

Measure	Placebo n=5 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Semaglutide n=6 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Change in Body Fat Percentage	0.13 Body fat percentage Standard Deviation 3.98	-2.70 Body fat percentage Standard Deviation 1.93

SECONDARY outcome

Timeframe: Assessed at end of 9 months

Proportion of participants who were newly added to a transplant list during study period. Assessed by Geisinger kidney transplant committee (blinded to randomization assignment, independent of investigators)

Outcome measures

Measure	Placebo n=7 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Semaglutide n=5 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
New Activation on the Transplant List	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Assessed at end of 9 months

Confirmed by review of electronic health record (EHR)

Outcome measures

Measure	Placebo n=7 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Semaglutide n=5 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Receipt of Kidney Transplant	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 9 months

Population: One patient in the placebo arm did not complete follow-up LDL measurement, and thus there is 1 less participant analyzed in the placebo arm.

Collected at a Geisinger lab using routine procedures and measured on the same day at the central Geisinger laboratory by spectrophotometry.

Outcome measures

Measure	Placebo n=6 Participants This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.	Semaglutide n=5 Participants This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Change in Low-Density Lipoprotein (LDL)	-6.17 mg/dL Standard Deviation 53.63	-6.20 mg/dL Standard Deviation 17.37

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 9 months

Collected at a Geisinger lab using routine procedures and measured on the same day at the central Geisinger laboratory by spectrophotometry.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 9 months

Automated office blood pressure (AOBP) will be measured (attended) using the OMRON 907-XL machine, with a 5-minute rest period in the seated position, followed by 3 measurements separated by 1-minute time intervals by trained research staff. Mid-arm circumference will be measured, and a cuff of appropriate size will be identified and the same size cuff will used for both visits.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 9 months

Automated office blood pressure (AOBP) will be measured (attended) using the OMRON 907-XL machine, with a 5-minute rest period in the seated position, followed by 3 measurements separated by 1-minute time intervals by trained research staff. Mid-arm circumference will be measured, and a cuff of appropriate size will be identified and the same size cuff will used for both visits.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 9 months

Testing at the central Geisinger laboratory, using immunoturbidimetry (albumin) and Jaffe/Enzymatic (Urine Creatinine)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 9 months

Testing at central Geisinger lab; Creatinine-based CKD-EPI equation

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Collected using Geisinger EHR data

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Collected using Geisinger EHR data using ICD codes for CVD-related hospitalizations

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Collected using Geisinger EHR data using ICD codes

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Collected using Geisinger EHR data

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Assessed at each study visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Assessed at each study visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Assessed at each study visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Assessed at each study visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Assessed at each study visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Assessed at each study visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Assessed at each study visit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Entire 9-month study period

Assessed at each study visit

Outcome measures

Outcome data not reported

Adverse Events

Semaglutide

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Semaglutide n=7 participants at risk This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.	Placebo n=8 participants at risk This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.
Cardiac disorders Syncope	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	12.5% 1/8 • Number of events 1 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Renal and urinary disorders Uremia	14.3% 1/7 • Number of events 1 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	12.5% 1/8 • Number of events 1 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Cardiac disorders Hypertensive urgency	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	12.5% 1/8 • Number of events 1 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Respiratory, thoracic and mediastinal disorders Pneumonia	28.6% 2/7 • Number of events 2 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	0.00% 0/8 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Infections and infestations Bacteremia	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	12.5% 1/8 • Number of events 1 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Gastrointestinal disorders Appendicitis	14.3% 1/7 • Number of events 1 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	0.00% 0/8 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.

Other adverse events

Measure	Semaglutide n=7 participants at risk This arm will receive semaglutide. Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.	Placebo n=8 participants at risk This arm will receive placebo. Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution: Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.
Endocrine disorders Hypoglycemia events	42.9% 3/7 • Number of events 3 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	50.0% 4/8 • Number of events 4 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Gastrointestinal disorders Gastrointestinal disorders	28.6% 2/7 • Number of events 5 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	25.0% 2/8 • Number of events 2 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Hepatobiliary disorders Gallbladder disorders	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	0.00% 0/8 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	0.00% 0/8 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Hepatobiliary disorders Hepatic events	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	0.00% 0/8 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Immune system disorders Allergic reactions	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	0.00% 0/8 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Skin and subcutaneous tissue disorders Injection-site reactions	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	0.00% 0/8 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Gastrointestinal disorders Acute pancreatitis	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	0.00% 0/8 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Blood and lymphatic system disorders Anemia or bleeding disorder	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	12.5% 1/8 • Number of events 3 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Respiratory, thoracic and mediastinal disorders shortness of breath	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	12.5% 1/8 • Number of events 1 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Skin and subcutaneous tissue disorders Foot ulcer	14.3% 1/7 • Number of events 1 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	0.00% 0/8 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.
Cardiac disorders Hypertension	0.00% 0/7 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.	12.5% 1/8 • Number of events 1 • 9 months Safety outcomes specifically assessed at each study visit systematically included: gastrointestinal disorders, gallbladder disorders, neoplasms, hepatic events, allergic reactions, injection-site reactions, hypoglycemia events, and acute pancreatitis events.

Additional Information

Alexander Chang

Geisinger

Phone: 570-271-8026

Email: achang@geisinger.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place