Trial Outcomes & Findings for A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation (NCT NCT04280081)

Last Updated: 2025-04-20

Results Overview

ORR is the summary measure of best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. BOR is defined as the best response designation for each participant that is recorded between the date of the first dose of selpercatinib and the date of documented disease progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first, and subsequently confirmed. BOR will be categorized as complete response (CR), partial response (PR). CR is defined as Disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR At least 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

Date of First Dose to Disease Progression or Death (up to 12 Months)

Results posted on

2025-04-20

Participant Flow

Enrollment for this study was based on tumor type.

Primary analysis set (PAS) is defined as rearranged transfection (RET) fusion positive non-small cell lung cancer (NSCLC) and thyroid cancer (TC) and RET mutant medullary thyroid cancer (MTC). Enrolled population is defined as all eligible participants.

Participant milestones

Participant milestones
Measure	Selpercatinib 160 milligram (mg) Selpercatinib administered orally twice daily (BID).
Overall Study STARTED	77
Overall Study Enrolled: All NSCLC	47
Overall Study Enrolled: All TC	1
Overall Study Enrolled: All MTC	29
Overall Study PAS: RET Fusion Positive NSCLC	26
Overall Study PAS: RET Fusion Positive TC	1
Overall Study PAS: Advance RET-mutant MTC	26
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Selpercatinib 160 milligram (mg) Selpercatinib administered orally twice daily (BID).
Overall Study Adverse Event	4
Overall Study Death	2
Overall Study Progressive Disease	6

Baseline Characteristics

A Study of Selpercatinib (LY3527723) in Participants With Advanced Solid Tumors Including RET Fusion-positive Solid Tumors, Medullary Thyroid Cancer and Other Tumors With RET Activation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Selpercatinib n=77 Participants 160 mg Selpercatinib administered orally BID.
Age, Continuous	50.60 years STANDARD_DEVIATION 12.87 • n=93 Participants
Sex: Female, Male Female	33 Participants n=93 Participants
Sex: Female, Male Male	44 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	77 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	0 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 China	77 Participants n=93 Participants

PRIMARY outcome

Timeframe: Date of First Dose to Disease Progression or Death (up to 12 Months)

Population: All treated participants who have confirmed RET fusion positive solid tumor NSCLC,TC, or RET mutant MTC by central lab, respectively.

Outcome measures

Outcome measures
Measure	RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 n=26 Participants 160 mg Selpercatinib administered orally BID.	RET Fusion Positive Thyroid Cancer (TC) Cohort 1 n=1 Participants 160 mg Selpercatinib administered orally BID.	RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 n=26 Participants 160 mg Selpercatinib administered orally BID.
Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) Complete Response	3.8 percentage of participants Interval 0.1 to 19.6	0 percentage of participants Interval 0.0 to 97.5	7.7 percentage of participants Interval 0.9 to 25.1
Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) Partial Response	65.4 percentage of participants Interval 44.3 to 82.8	100.0 percentage of participants Interval 2.5 to 100.0	50.0 percentage of participants Interval 29.9 to 70.1
Primary Analysis Set: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by Independent Review Committee (IRC) Overall Response (CR/PR)	69.2 percentage of participants Interval 48.2 to 85.7	100.0 percentage of participants Interval 2.5 to 100.0	57.7 percentage of participants Interval 36.9 to 76.6

PRIMARY outcome

Timeframe: Date of First Dose to Disease Progression or Death (Up to 12 months)

Population: All eligible participants.

Outcome measures

Outcome measures
Measure	RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 n=47 Participants 160 mg Selpercatinib administered orally BID.	RET Fusion Positive Thyroid Cancer (TC) Cohort 1 n=1 Participants 160 mg Selpercatinib administered orally BID.	RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 n=29 Participants 160 mg Selpercatinib administered orally BID.
Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC Complete Response	6.4 percentage of participants Interval 1.3 to 17.5	0 percentage of participants Interval 0.0 to 97.5	10.3 percentage of participants Interval 2.2 to 27.4
Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC Partial Response	59.6 percentage of participants Interval 44.3 to 73.6	100.0 percentage of participants Interval 2.5 to 100.0	48.3 percentage of participants Interval 29.4 to 67.5
Enrolled Population: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR) as Assessed by IRC Overall Response (CR/PR)	66.0 percentage of participants Interval 50.7 to 79.1	100.0 percentage of participants Interval 2.5 to 100.0	58.6 percentage of participants Interval 38.9 to 76.5

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 11 Months)

Population: All eligible participants with confirmed response. Number of participants censored: All NSCLC = 30, All TC = 1, and All MTC = 16.

DOR is defined as the number of months from the start date of PR or CR (whichever response is recorded first), and subsequently confirmed, to the date of disease progression or death, whichever occurs earlier.

Outcome measures

Outcome measures
Measure	RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 n=31 Participants 160 mg Selpercatinib administered orally BID.	RET Fusion Positive Thyroid Cancer (TC) Cohort 1 n=1 Participants 160 mg Selpercatinib administered orally BID.	RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 n=17 Participants 160 mg Selpercatinib administered orally BID.
Enrolled Population: Duration of Response (DoR) as Assessed by IRC	NA months Median not evaluable due to number of participants censored.	NA months Median not evaluable due to number of participants censored.	NA months Median not evaluable due to number of participants censored.

SECONDARY outcome

Timeframe: Date of First Dose to First Occurrence of Confirmed Tumor Response (Up to 6 months)

Population: All eligible participants with confirmed response.

TTR is defined as the number of months elapsed between the date of the first dose of selpercatinib and the first documentation of objective response (CR or PR, whichever occurs earlier) that is subsequently confirmed.

Outcome measures

Outcome measures
Measure	RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 n=31 Participants 160 mg Selpercatinib administered orally BID.	RET Fusion Positive Thyroid Cancer (TC) Cohort 1 n=1 Participants 160 mg Selpercatinib administered orally BID.	RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 n=17 Participants 160 mg Selpercatinib administered orally BID.
Enrolled Population: Time to Response (TTR) as Assessed by IRC	1.84 months Interval 1.74 to 1.87	1.74 months Interval 1.74 to 1.74	1.84 months Interval 1.81 to 3.71

SECONDARY outcome

Timeframe: Date of First Dose to First Occurrence of PR (If Subject's Best Overall Response [BOR] is PR) or CR (If Subject's BOR is CR) (Up to 8 months)

Population: All eligible patients with confirmed response.

Outcome measures

Outcome measures
Measure	RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 n=31 Participants 160 mg Selpercatinib administered orally BID.	RET Fusion Positive Thyroid Cancer (TC) Cohort 1 n=1 Participants 160 mg Selpercatinib administered orally BID.	RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 n=17 Participants 160 mg Selpercatinib administered orally BID.
Enrolled Population: Time to Best Response (TTBR) as Assessed by IRC	1.84 months Interval 1.77 to 1.87	1.74 months Interval 1.74 to 1.74	1.87 months Interval 1.81 to 5.16

SECONDARY outcome

Timeframe: Baseline through Disease Progression or Death Due to Any Cause (Up to 12 Months)

Population: All eligible participants.

CBR based on the percentage of participants with best overall response of CR, PR, or stable disease (SD) lasting 16 or more weeks following initiation of selpercatinib as assessed by IRC. CR is defined as disappearance of all target lesions. Any pathologic nodes (whether target or non-target lesions) must have a reduction in short axis diameter (SAD) to less than 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters (SOD) (LD for non-nodal lesions) and SAD for nodal lesions) of target lesions, taking as reference the baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 n=47 Participants 160 mg Selpercatinib administered orally BID.	RET Fusion Positive Thyroid Cancer (TC) Cohort 1 n=1 Participants 160 mg Selpercatinib administered orally BID.	RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 n=29 Participants 160 mg Selpercatinib administered orally BID.
Enrolled Population: Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR, or Stable Disease (SD) With a Duration of At Least 16 or More Weeks as Assessed by IRC	76.6 percentage of participants Interval 62.0 to 87.7	100.0 percentage of participants Interval 2.5 to 100.0	65.5 percentage of participants Interval 45.7 to 82.1

SECONDARY outcome

Timeframe: Baseline to Progressive Disease or Death from Any Cause (Up to 12 Months)

Population: All eligible participants. Number of participants censored: All NSCLC = 40; All TC = 1, and All MTC = 28

PFS is defined as the number of months elapsed between the date of the first dose and the earliest date of documented disease progression or death (whatever the cause). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study) for target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5.0 mm. Progressive disease for non-target lesion is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 n=47 Participants 160 mg Selpercatinib administered orally BID.	RET Fusion Positive Thyroid Cancer (TC) Cohort 1 n=1 Participants 160 mg Selpercatinib administered orally BID.	RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 n=29 Participants 160 mg Selpercatinib administered orally BID.
Enrolled Population: Progression Free Survival (PFS) as Assessed by IRC	NA months Median and CI not available due to censoring.	NA months Median and CI not available due to censoring.	NA months Median and CI not available due to censoring.

SECONDARY outcome

Timeframe: Baseline to Date of Death from Any Cause (Up to 12 Months)

Population: All eligible participants. Number of participants censored: All NSCLC = 42, All TC = 1, and All MTC = 28.

OS is defined as the number of months elapsed between the date of the first dose and the date of death (whatever the cause). Participants who are alive or lost to follow-up as of the data cutoff date will be right-censored.

Outcome measures

Outcome measures
Measure	RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 n=47 Participants 160 mg Selpercatinib administered orally BID.	RET Fusion Positive Thyroid Cancer (TC) Cohort 1 n=1 Participants 160 mg Selpercatinib administered orally BID.	RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 n=29 Participants 160 mg Selpercatinib administered orally BID.
Enrolled Population: Overall Survival (OS)	NA months Median and CI not available due to censoring.	NA months Median and CI not available due to censoring.	NA months Median and CI not available due to censoring.

SECONDARY outcome

Timeframe: PK: Cycle 1 Day 1: Predose, 1 h, 2, h, 4 h, 8 h, 12 h postdose PK: Cycle 1 Day 8: Predose, 1 h, 2, h, 4 h, 8 h postdose

Population: All randomized participants who received at least one dose of study drug and had evaluable intensive PK data per protocol.

Serial blood samples for intensive PK monitoring will be collected for 12 participants.

Outcome measures

Outcome measures
Measure	RET Fusion Positive Non-small Cell Lung Cancer (NSCLC) Cohort 1 n=12 Participants 160 mg Selpercatinib administered orally BID.	RET Fusion Positive Thyroid Cancer (TC) Cohort 1 160 mg Selpercatinib administered orally BID.	RET Mutant Medullary Thyroid Cancer (MTC) Cohort 2 160 mg Selpercatinib administered orally BID.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Selpercatinib Cycle 1 Day 1	11700 nanogram * hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 56.8	—	—
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Selpercatinib Cycle 1 Day 8	37900 nanogram * hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 54	—	—

Adverse Events

Selpercatinib

Serious events: 17 serious events

Other events: 75 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Selpercatinib n=77 participants at risk 160 mg Selpercatinib administered orally twice daily (BID).
Endocrine disorders Cushing's syndrome	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Pancreatitis	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Pancreatitis acute	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	2.6% 2/77 • Number of events 2 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hepatic function abnormal	3.9% 3/77 • Number of events 3 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Jaundice	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Liver injury	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Hypersensitivity	3.9% 3/77 • Number of events 3 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Alanine aminotransferase increased	2.6% 2/77 • Number of events 2 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	3.9% 3/77 • Number of events 3 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatinine increased	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Gamma-glutamyltransferase increased	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Platelet count decreased	3.9% 3/77 • Number of events 3 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	2.3% 1/44 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Reproductive system and breast disorders Prostatic obstruction	2.3% 1/44 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Chylothorax	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	1.3% 1/77 • Number of events 1 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Other adverse events

Other adverse events
Measure	Selpercatinib n=77 participants at risk 160 mg Selpercatinib administered orally twice daily (BID).
Blood and lymphatic system disorders Anaemia	16.9% 13/77 • Number of events 14 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	6.5% 5/77 • Number of events 9 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	6.5% 5/77 • Number of events 8 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus bradycardia	6.5% 5/77 • Number of events 6 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Cardiac disorders Sinus tachycardia	7.8% 6/77 • Number of events 7 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Hypothyroidism	10.4% 8/77 • Number of events 11 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Endocrine disorders Thyroid disorder	10.4% 8/77 • Number of events 12 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Ascites	5.2% 4/77 • Number of events 4 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	14.3% 11/77 • Number of events 12 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	32.5% 25/77 • Number of events 136 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	28.6% 22/77 • Number of events 23 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	5.2% 4/77 • Number of events 5 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	6.5% 5/77 • Number of events 8 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Chest pain	7.8% 6/77 • Number of events 7 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Face oedema	6.5% 5/77 • Number of events 5 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	10.4% 8/77 • Number of events 9 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Oedema peripheral	7.8% 6/77 • Number of events 8 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Pyrexia	22.1% 17/77 • Number of events 22 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Swelling face	6.5% 5/77 • Number of events 5 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Hyperbilirubinaemia	6.5% 5/77 • Number of events 9 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Immune system disorders Hypersensitivity	11.7% 9/77 • Number of events 9 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Adenosine deaminase increased	5.2% 4/77 • Number of events 4 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Alanine aminotransferase increased	64.9% 50/77 • Number of events 73 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	61.0% 47/77 • Number of events 83 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Bilirubin conjugated increased	26.0% 20/77 • Number of events 34 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	27.3% 21/77 • Number of events 32 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood bilirubin increased	39.0% 30/77 • Number of events 69 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood bilirubin unconjugated increased	7.8% 6/77 • Number of events 8 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood creatinine increased	23.4% 18/77 • Number of events 30 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood lactate dehydrogenase increased	23.4% 18/77 • Number of events 33 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood thyroid stimulating hormone increased	11.7% 9/77 • Number of events 13 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Blood urea increased	6.5% 5/77 • Number of events 7 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Electrocardiogram qt prolonged	24.7% 19/77 • Number of events 34 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Electrocardiogram t wave abnormal	13.0% 10/77 • Number of events 12 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Electrocardiogram t wave amplitude decreased	6.5% 5/77 • Number of events 6 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Gamma-glutamyltransferase increased	22.1% 17/77 • Number of events 23 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Globulins decreased	5.2% 4/77 • Number of events 4 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Lymphocyte count decreased	11.7% 9/77 • Number of events 13 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Neutrophil count decreased	26.0% 20/77 • Number of events 41 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Platelet count decreased	37.7% 29/77 • Number of events 47 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Protein total decreased	15.6% 12/77 • Number of events 27 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Thyroxine increased	6.5% 5/77 • Number of events 6 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Total bile acids increased	13.0% 10/77 • Number of events 17 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Tri-iodothyronine decreased	6.5% 5/77 • Number of events 6 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Urine bilirubin increased	6.5% 5/77 • Number of events 7 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight decreased	9.1% 7/77 • Number of events 9 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations Weight increased	23.4% 18/77 • Number of events 25 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Investigations White blood cell count decreased	32.5% 25/77 • Number of events 39 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	11.7% 9/77 • Number of events 9 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	15.6% 12/77 • Number of events 17 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperphosphataemia	14.3% 11/77 • Number of events 21 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	24.7% 19/77 • Number of events 36 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	33.8% 26/77 • Number of events 40 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	18.2% 14/77 • Number of events 19 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypochloraemia	5.2% 4/77 • Number of events 5 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	15.6% 12/77 • Number of events 20 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	9.1% 7/77 • Number of events 9 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	16.9% 13/77 • Number of events 16 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypophosphataemia	5.2% 4/77 • Number of events 6 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Proteinuria	19.5% 15/77 • Number of events 22 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	5.2% 4/77 • Number of events 7 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 7/77 • Number of events 7 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.2% 4/77 • Number of events 4 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	15.6% 12/77 • Number of events 13 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Vascular disorders Hypertension	35.1% 27/77 • Number of events 42 • Baseline up to 12 Months All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-595-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60