Trial Outcomes & Findings for A Study of LY2599506 in Patients With Type 2 Diabetes (NCT NCT01024244)

Last Updated: 2011-12-02

Results Overview

Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2011-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	0 Milligrams (mg) Placebo Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.	100 mg LY2599506 Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.	200 mg LY2599506 Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	400 mg LY2599506 Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	200 mg LY2599506 Once Daily Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
Overall Study STARTED	22	12	15	14	15
Overall Study COMPLETED	5	1	1	1	1
Overall Study NOT COMPLETED	17	11	14	13	14

Reasons for withdrawal

Reasons for withdrawal
Measure	0 Milligrams (mg) Placebo Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.	100 mg LY2599506 Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.	200 mg LY2599506 Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	400 mg LY2599506 Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	200 mg LY2599506 Once Daily Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
Overall Study Adverse Event	1	2	0	1	2
Overall Study Entry Criteria Not Met	0	1	0	0	0
Overall Study Lack of Efficacy	1	0	0	0	0
Overall Study Protocol Violation	1	0	0	0	2
Overall Study Sponsor Decision	14	7	14	12	10
Overall Study Withdrawal by Subject	0	1	0	0	0

Baseline Characteristics

A Study of LY2599506 in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0 Milligrams (mg) Placebo n=22 Participants Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.	100 mg LY2599506 n=12 Participants Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.	200 mg LY2599506 n=15 Participants Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	400 mg LY2599506 n=14 Participants Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	200 mg LY2599506 Once Daily n=15 Participants Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).	Total n=78 Participants Total of all reporting groups
Age Continuous	56.69 years STANDARD_DEVIATION 7.60 • n=93 Participants	55.94 years STANDARD_DEVIATION 6.66 • n=4 Participants	56.55 years STANDARD_DEVIATION 7.53 • n=27 Participants	59.94 years STANDARD_DEVIATION 10.88 • n=483 Participants	59.25 years STANDARD_DEVIATION 5.83 • n=36 Participants	57.62 years STANDARD_DEVIATION 7.81 • n=10 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	4 Participants n=483 Participants	5 Participants n=36 Participants	28 Participants n=10 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants	10 Participants n=483 Participants	10 Participants n=36 Participants	50 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	8 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=93 Participants	9 Participants n=4 Participants	14 Participants n=27 Participants	13 Participants n=483 Participants	15 Participants n=36 Participants	70 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Region of Enrollment Australia	0 participants n=93 Participants	1 participants n=4 Participants	0 participants n=27 Participants	3 participants n=483 Participants	4 participants n=36 Participants	8 participants n=10 Participants
Region of Enrollment Puerto Rico	3 participants n=93 Participants	2 participants n=4 Participants	1 participants n=27 Participants	1 participants n=483 Participants	0 participants n=36 Participants	7 participants n=10 Participants
Region of Enrollment Russian Federation	4 participants n=93 Participants	3 participants n=4 Participants	7 participants n=27 Participants	4 participants n=483 Participants	3 participants n=36 Participants	21 participants n=10 Participants
Region of Enrollment Spain	11 participants n=93 Participants	4 participants n=4 Participants	6 participants n=27 Participants	5 participants n=483 Participants	5 participants n=36 Participants	31 participants n=10 Participants
Region of Enrollment United States	4 participants n=93 Participants	2 participants n=4 Participants	1 participants n=27 Participants	1 participants n=483 Participants	3 participants n=36 Participants	11 participants n=10 Participants
Duration of Diabetes in Years	5.71 years STANDARD_DEVIATION 4.26 • n=93 Participants	3.55 years STANDARD_DEVIATION 4.87 • n=4 Participants	5.54 years STANDARD_DEVIATION 4.43 • n=27 Participants	5.12 years STANDARD_DEVIATION 3.34 • n=483 Participants	5.78 years STANDARD_DEVIATION 4.15 • n=36 Participants	5.25 years STANDARD_DEVIATION 4.18 • n=10 Participants
Percentage of Glycosylated Fraction of Hemoglobin A1c	8.10 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.63 • n=93 Participants	7.48 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.71 • n=4 Participants	7.89 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.45 • n=27 Participants	7.88 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.74 • n=483 Participants	7.79 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.83 • n=36 Participants	7.86 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.69 • n=10 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: Data were reviewed but are not presented due to insufficient sample size.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: The QT interval was not analyzed due to insufficient sample size.

Measures the QT interval in the ECG. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: HOMA2 (%B) was not calculated due to insufficient sample size.

HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: HOMA2 (%S) was not calculated due to insufficient sample size.

HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: Data were reviewed but not presented due to insufficient sample size.

Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: Quality of life data were not analyzed due to insufficient sample size.

Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: Data were reviewed but are not presented due to insufficient sample size.

Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBPB minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 16 weeks

Population: Data were reviewed but are not presented due to insufficient sample size.

Hypoglycemia was defined as any time a participant feels s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose \<70 mg/dL (3.9 mmol/L) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: Data were reviewed but are not presented due to insufficient sample size.

Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 12 weeks, 16 weeks

Population: Data were reviewed but are not presented due to insufficient sample size.

SMBG levels were measured at the following 7 timepoints during the day: fasting pre-breakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 12 weeks

Population: Data were reviewed but are not presented due to insufficient sample size.

Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose\<70 milligrams per deciliter (mg/dL). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 12 weeks

Population: Data were reviewed but are not presented due to insufficient sample size.

Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 12 weeks, Baseline through 16 weeks

Population: Only randomized participants with a baseline value and at least 1 post-baseline value of the response variable were included in the analysis.

Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.

Outcome measures

Outcome measures
Measure	0 Milligrams (mg) Placebo n=22 Participants Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.	100 mg LY2599506 n=12 Participants Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.	200 mg LY2599506 n=15 Participants Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	400 mg LY2599506 n=14 Participants Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	200 mg LY2599506 Once Daily n=15 Participants Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period	0.0 percentage of participants	25.0 percentage of participants	26.7 percentage of participants	0.0 percentage of participants	6.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: Quality of life data were not analyzed due to insufficient sample size.

DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: Quality of life data were not analyzed due to insufficient sample size.

Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: Quality of life data were not analyzed due to insufficient sample size.

Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 12 weeks

Population: No participants had data analyzed due to insufficient sample size.

The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12

Population: Data were reviewed but are not presented due to the insufficient sample size and the sparse sampling approach.

The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12

Population: Data were reviewed but are not presented due to the insufficient sample size and sparse sampling approach.

The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 16 weeks

Population: Data were reviewed but are not presented due to insufficient sample size.

Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose \<70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 16 weeks

Population: Data were reviewed but are not presented due to insufficient sample size.

Heart rate was measured in heartbeats per minute. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.

Outcome measures

Outcome data not reported

Adverse Events

0 Milligrams (mg) Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

100 mg LY2599506

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

200 mg LY2599506

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

400 mg LY2599506

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

200 mg LY2599506 Once Daily

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0 Milligrams (mg) Placebo n=22 participants at risk Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.	100 mg LY2599506 n=12 participants at risk Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.	200 mg LY2599506 n=15 participants at risk Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	400 mg LY2599506 n=14 participants at risk Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	200 mg LY2599506 Once Daily n=15 participants at risk Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
Gastrointestinal disorders Pancreatitis acute	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/22	0.00% 0/12	0.00% 0/15	0.00% 0/14	6.7% 1/15 • Number of events 1
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/22	0.00% 0/12	0.00% 0/15	0.00% 0/14	6.7% 1/15 • Number of events 1

Other adverse events

Other adverse events
Measure	0 Milligrams (mg) Placebo n=22 participants at risk Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.	100 mg LY2599506 n=12 participants at risk Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.	200 mg LY2599506 n=15 participants at risk Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	400 mg LY2599506 n=14 participants at risk Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.	200 mg LY2599506 Once Daily n=15 participants at risk Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
Cardiac disorders Angina pectoris	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Cardiac disorders Atrial fibrillation	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Endocrine disorders Adrenal mass	0.00% 0/22	0.00% 0/12	0.00% 0/15	0.00% 0/14	6.7% 1/15 • Number of events 1
Eye disorders Eye swelling	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Gastrointestinal disorders Abdominal pain	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Gastrointestinal disorders Constipation	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Gastrointestinal disorders Dyspepsia	0.00% 0/22	0.00% 0/12	0.00% 0/15	0.00% 0/14	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Flatulence	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Gastrointestinal disorders Vomiting	0.00% 0/22	0.00% 0/12	0.00% 0/15	0.00% 0/14	6.7% 1/15 • Number of events 1
General disorders Chest pain	0.00% 0/22	0.00% 0/12	0.00% 0/15	0.00% 0/14	6.7% 1/15 • Number of events 1
General disorders Fatigue	4.5% 1/22 • Number of events 1	0.00% 0/12	0.00% 0/15	0.00% 0/14	0.00% 0/15
General disorders Premature ageing	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Hepatobiliary disorders Hepatitis acute	0.00% 0/22	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/14	0.00% 0/15
Infections and infestations Gastroenteritis viral	0.00% 0/22	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/14	0.00% 0/15
Infections and infestations Influenza	4.5% 1/22 • Number of events 1	0.00% 0/12	0.00% 0/15	0.00% 0/14	0.00% 0/15
Infections and infestations Nasopharyngitis	0.00% 0/22	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/14	6.7% 1/15 • Number of events 1
Injury, poisoning and procedural complications Contusion	4.5% 1/22 • Number of events 1	0.00% 0/12	0.00% 0/15	0.00% 0/14	0.00% 0/15
Investigations Blood glucose increased	4.5% 1/22 • Number of events 1	0.00% 0/12	0.00% 0/15	0.00% 0/14	0.00% 0/15
Investigations Lipase increased	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Investigations Liver function test abnormal	0.00% 0/22	8.3% 1/12 • Number of events 1	0.00% 0/15	14.3% 2/14 • Number of events 2	6.7% 1/15 • Number of events 1
Investigations Weight decreased	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/22	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/14	0.00% 0/15
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/22	0.00% 0/12	0.00% 0/15	0.00% 0/14	6.7% 1/15 • Number of events 1
Nervous system disorders Headache	0.00% 0/22	16.7% 2/12 • Number of events 2	6.7% 1/15 • Number of events 1	14.3% 2/14 • Number of events 3	0.00% 0/15
Nervous system disorders Lethargy	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Nervous system disorders Migraine	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 2	0.00% 0/15
Nervous system disorders Paraesthesia	0.00% 0/22	8.3% 1/12 • Number of events 1	0.00% 0/15	0.00% 0/14	0.00% 0/15
Reproductive system and breast disorders Testicular pain	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Skin and subcutaneous tissue disorders Rash macular	4.5% 1/22 • Number of events 1	0.00% 0/12	0.00% 0/15	0.00% 0/14	0.00% 0/15
Skin and subcutaneous tissue disorders Rash papular	4.5% 1/22 • Number of events 1	0.00% 0/12	0.00% 0/15	0.00% 0/14	0.00% 0/15
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/22	0.00% 0/12	0.00% 0/15	7.1% 1/14 • Number of events 1	0.00% 0/15
Skin and subcutaneous tissue disorders Rosacea	4.5% 1/22 • Number of events 1	0.00% 0/12	0.00% 0/15	0.00% 0/14	0.00% 0/15
Skin and subcutaneous tissue disorders Skin exfoliation	4.5% 1/22 • Number of events 1	0.00% 0/12	0.00% 0/15	0.00% 0/14	0.00% 0/15

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60