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CompletedNCT03951753Updated Mar 20, 2023Results posted

A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

A Phase 1 interventional study of Tirzepatide and Semaglutide in Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Completed at 2 sites in Germany. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-03-20.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
20 Years to 74 Years
Sex
All
01

Study summary

This is a study for participants with type 2 diabetes mellitus. The main purpose of this study is to learn more about how tirzepatide, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal. The study will last up to 40 weeks, including a 28-week treatment period.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 117 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have T2DM for at least 6 months
  • Treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry
  • Have a hemoglobin A1c (HbA1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin
  • Have a body mass index (BMI) between 25 and 45 kilograms per square meter (kg/m² ) inclusive, at screening; are of stable weight (±5%) >3 months prior to screening

Exclusion criteria

Exclusion Criteria:

  • Have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (\<1.5 years) ophthalmologic examination
  • Impaired renal estimated glomerular filtration rate (eGFR) \<45 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
  • Have a history or current cardiovascular, respiratory, hepatic, renal, GI,endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
117 participants (actual)

Study arms

  • Experimental
    Tirzepatide 15 mg

    Participants received 15 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 28 weeks.

    Drug: Tirzepatide

  • Active comparator
    Semaglutide 1 mg

    Participants received 1 mg Semaglutide administered SC once weekly for 28 weeks.

    Drug: Semaglutide

  • Placebo comparator
    Placebo

    Participants received Placebo administered SC once weekly for 28 weeks.

    Drug: Placebo

Interventions

  • DrugTirzepatide

    Administered SC

    Also known as: LY3298176

  • DrugSemaglutide

    Administered SC

  • DrugPlacebo

    Administered SC

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Total Clamp Disposition Index (cDI)

    cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR AUC0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study. Least squares (LS) mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).

    Time frame: Baseline, Week 28

Secondary outcomes

  1. Change From Baseline in Fasting Glucose

    Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. Fasting glucose was measured prior to standardized mixed-meal tolerance tests (sMMTT). LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

    Time frame: Baseline, Week 28

  2. Change From Baseline in Postmeal Glucose

    Total AUC from time zero to 240 minutes after start of the meal \[AUC0-240min\]) during sMMTT was evaluated. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares) and ANOVA model for baseline measures: Variable = Treatment (Type III sum of squares).

    Time frame: Baseline, Week 28

  3. Change From Baseline in Hemoglobin A1c (HbA1c)

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by mixed model repeated measures; (MMRM) model for post-baseline measures: Variable = Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

    Time frame: Baseline, Week 28

  4. Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min)

    Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min) will be determined from C-peptide concentrations using the deconvolution technique. LS mean was determined by ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).

    Time frame: Baseline and Week 28

  5. Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value

    Hyperinsulinemic euglycemic clamp M-value is calculated from glucose infusion rate (GIR) over the last 30 minutes, corresponding to steady-state (+150 to +180 minutes), corrected for urine loss and space. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

    Time frame: Baseline, Week 28

  6. Change From Baseline in Glucagon Concentration at Fasting

    Glucagon concentration was measured prior to sMMTT. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

    Time frame: Baseline and Week 28

  7. Change From Baseline in Glucagon Concentration at Postmeal

    Total AUC from time zero to 240 minutes after start of the meal \[AUC0-240min\]) during sMMTT. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

    Time frame: Baseline and Week 28

  8. Change From Baseline in Food Intake During Ad Libitum Meal

    Ad libitum meal served buffet-style. Food intake was recorded during a 45 minute period. The sum of the caloric breakdown (carbohydrates, protein, and fats) was calculated from the respective nutritional information of the food items. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

    Time frame: Baseline, Week 28

07

Results

Posted Mar 20, 2023

Participant flow

Participant flow — Overall Study
MilestoneTirzepatide 15 mgSemaglutide 1 mgPlacebo
Started454428
Completed414324
Not completed414
Withdrew: Adverse event103
Withdrew: Withdrawal by subject310
Withdrew: Lost to follow-up001

Outcome measures

PrimaryChange From Baseline in Total Clamp Disposition Index (cDI)

cDI is defined as the product of the M-value derived from the hyperinsulinemic euglycemic clamp over the last 30 minutes and total insulin secretion (ISR AUC0-120min) derived from the insulin secretion rate based on C-peptide using the using the deconvolution technique divided by the total glucose AUC0-120min from the hyperglycemic clamp portion of the study. Least squares (LS) mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · pmol*m-2*L*min-2*kg-1
Change From Baseline in Total Clamp Disposition Index (cDI)
pmol*m-2*L*min-2*kg-1Tirzepatide 15 mgSemaglutide 1 mgPlacebo
Change From Baseline in Total Clamp Disposition Index (cDI)1.9 ± 0.161.1 ± 0.100.0 ± 0.03
Statistical analysis
  • Semaglutide 1 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: 1.08 · 95% CI 0.87 to 1.29Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.
  • Tirzepatide 15 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: 1.92 · 95% CI 1.59 to 2.24Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.
  • Tirzepatide 15 mg vs Semaglutide 1 mg · ANCOVA · p = <0.001 · Least squares mean difference: 0.84 · 95% CI 0.46 to 1.21Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.
SecondaryChange From Baseline in Fasting Glucose

Fasting glucose is a test to determine sugar levels in blood sample after an overnight fast. Fasting glucose was measured prior to standardized mixed-meal tolerance tests (sMMTT). LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · milligrams per decilitre (mg/dL)
Change From Baseline in Fasting Glucose
milligrams per decilitre (mg/dL)Tirzepatide 15 mgSemaglutide 1 mgPlacebo
Change From Baseline in Fasting Glucose-51.4 ± 2.30-42.4 ± 2.22-4.3 ± 2.98
Statistical analysis
  • Semaglutide 1 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: -38.1 · 95% CI -45.4 to -30.7
  • Tirzepatide 15 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: -47.1 · 95% CI -54.6 to -39.5
  • Tirzepatide 15 mg vs Semaglutide 1 mg · ANCOVA · p = 0.006 · Least squares mean difference: -9.0 · 95% CI -15.4 to -2.6
SecondaryChange From Baseline in Postmeal Glucose

Total AUC from time zero to 240 minutes after start of the meal \[AUC0-240min\]) during sMMTT was evaluated. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares) and ANOVA model for baseline measures: Variable = Treatment (Type III sum of squares).

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · Milligrams per decilitre*minute
Change From Baseline in Postmeal Glucose
Milligrams per decilitre*minuteTirzepatide 15 mgSemaglutide 1 mgPlacebo
Change From Baseline in Postmeal Glucose-17414.0 ± 726.0214236.9 ± 709.53459.2 ± 947.50
Statistical analysis
  • Semaglutide 1 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: -14696.1 · 95% CI -17045.0 to -12347.3
  • Tirzepatide 15 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: -17873.2 · 95% CI -20239.0 to -15507.4
  • Tirzepatide 15 mg vs Semaglutide 1 mg · ANCOVA · p = 0.002 · Least squares mean difference: -3177.1 · 95% CI -5194.3 to -1159.8
SecondaryChange From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by mixed model repeated measures; (MMRM) model for post-baseline measures: Variable = Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · % of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c)
% of HbA1cTirzepatide 15 mgSemaglutide 1 mgPlacebo
Change From Baseline in Hemoglobin A1c (HbA1c)2.05 ± 0.079-1.64 ± 0.0780.29 ± 0.101
Statistical analysis
  • Semaglutide 1 mg vs Placebo · Mixed Models Analysis · p = <0.001 · Least squares mean difference: -1.93 · 95% CI -2.18 to -1.67
  • Tirzepatide 15 mg vs Placebo · Mixed Models Analysis · p = <0.001 · Least squares mean difference: -2.33 · 95% CI -2.58 to -2.08
  • Tirzepatide 15 mg vs Semaglutide 1 mg · Mixed Models Analysis · p = <0.001 · Least squares mean difference: -0.41 · 95% CI -0.63 to -0.19
SecondaryChange From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min)

Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min) will be determined from C-peptide concentrations using the deconvolution technique. LS mean was determined by ANCOVA model for endpoint measures: log(Actual Measurement/Baseline) = log(Baseline) + Treatment (Type III sum of squares).

Time frame:
Baseline and Week 28
Reported as:
Least squares mean · pmol/min/m^2
Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min)
pmol/min/m^2Tirzepatide 15 mgSemaglutide 1 mgPlacebo
Change From Baseline in Total Insulin Secretion Rate During the 120-Minute Hyperglycemic Clamp (ISR0-120min)388.6 ± 20.17286.6 ± 15.827.4 ± 7.15
Statistical analysis
  • Semaglutide 1 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: 279.14 · 95% CI 245.10 to 313.18Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.
  • Tirzepatide 15 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: 381.23 · 95% CI 339.29 to 423.17Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.
  • Tirzepatide 15 mg vs Semaglutide 1 mg · ANCOVA · p = <0.001 · Least squares mean difference: 102.09 · 95% CI 51.84 to 152.33Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.
SecondaryChange From Baseline in Hyperinsulinemic Euglycemic Clamp M-value

Hyperinsulinemic euglycemic clamp M-value is calculated from glucose infusion rate (GIR) over the last 30 minutes, corresponding to steady-state (+150 to +180 minutes), corrected for urine loss and space. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · umol/min/kg [body weight]
Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value
umol/min/kg [body weight]Tirzepatide 15 mgSemaglutide 1 mgPlacebo
Change From Baseline in Hyperinsulinemic Euglycemic Clamp M-value19.2 ± 1.9310.7 ± 1.99-0.6 ± 2.53
Statistical analysis
  • Semaglutide 1 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: 11.3 · 95% CI 4.9 to 17.7
  • Tirzepatide 15 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: 19.8 · 95% CI 13.4 to 26.1
  • Tirzepatide 15 mg vs Semaglutide 1 mg · ANCOVA · p = 0.003 · Least squares mean difference: 8.5 · 95% CI 3.0 to 14.0
SecondaryChange From Baseline in Glucagon Concentration at Fasting

Glucagon concentration was measured prior to sMMTT. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

Time frame:
Baseline and Week 28
Reported as:
Least squares mean · picomoles per litre (pmol/L)
Change From Baseline in Glucagon Concentration at Fasting
picomoles per litre (pmol/L)Tirzepatide 15 mgSemaglutide 1 mgPlacebo
Change From Baseline in Glucagon Concentration at Fasting-3.6 ± 0.55-2.8 ± 0.550.8 ± 0.75
Statistical analysis
  • Semaglutide 1 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: -3.6 · 95% CI -5.5 to -1.8
  • Tirzepatide 15 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: -4.5 · 95% CI -6.3 to -2.6
  • Tirzepatide 15 mg vs Semaglutide 1 mg · ANCOVA · p = 0.277 · Least squares mean difference: -0.8 · 95% CI -2.4 to 0.7
SecondaryChange From Baseline in Glucagon Concentration at Postmeal

Total AUC from time zero to 240 minutes after start of the meal \[AUC0-240min\]) during sMMTT. LS mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Treatment (Type III sum of squares).

Time frame:
Baseline and Week 28
Reported as:
Least squares mean · (pmol/L)*min
Change From Baseline in Glucagon Concentration at Postmeal
(pmol/L)*minTirzepatide 15 mgSemaglutide 1 mgPlacebo
Change From Baseline in Glucagon Concentration at Postmeal-843.6 ± 86.26-502.0 ± 87.33-205.9 ± 116.31
Statistical analysis
  • Semaglutide 1 mg vs Placebo · ANCOVA · p = 0.044 · Slope: -296.1 · 95% CI -584.8 to -7.5
  • Tirzepatide 15 mg vs Placebo · ANCOVA · p = <0.001 · Least squares mean difference: -637.7 · 95% CI -925.2 to -350.2
  • Tirzepatide 15 mg vs Semaglutide 1 mg · ANCOVA · p = 0.006 · Least squares mean difference: -341.6 · 95% CI -585.2 to -97.9
SecondaryChange From Baseline in Food Intake During Ad Libitum Meal

Ad libitum meal served buffet-style. Food intake was recorded during a 45 minute period. The sum of the caloric breakdown (carbohydrates, protein, and fats) was calculated from the respective nutritional information of the food items. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares).

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · kilocalorie (kcal)
Change From Baseline in Food Intake During Ad Libitum Meal
kilocalorie (kcal)Tirzepatide 15 mgSemaglutide 1 mgPlacebo
Change From Baseline in Food Intake During Ad Libitum Meal-348.4 ± 34.59-284.1 ± 33.94-38.6 ± 45.17
Statistical analysis
  • Semaglutide 1 mg vs Placebo · Mixed Models Analysis · p = <0.001 · Least squares mean difference: -245.5 · 95% CI -357.7 to -133.3
  • Tirzepatide 15 mg vs Placebo · Mixed Models Analysis · p = <0.001 · Least squares mean difference: -309.8 · 95% CI -423.0 to -196.6
  • Tirzepatide 15 mg vs Semaglutide 1 mg · Mixed Models Analysis · p = 0.187 · Least squares mean difference: -64.3 · 95% CI -160.3 to 31.7

Adverse events

Collected over Up to Week 32. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/28 (0%)2/28 (7.1%)18/28 (64.3%)
Semaglutide 1 mg0/44 (0%)0/44 (0%)43/44 (97.7%)
Tirzepatide 15 mg0/45 (0%)1/45 (2.2%)41/45 (91.1%)
Most frequent serious events
Most frequent serious events
EventPlaceboSemaglutide 1 mgTirzepatide 15 mg
Acute myocardial infarctionCardiac disorders1/280/440/45
Subacute pancreatitisGastrointestinal disorders1/280/440/45
UreterolithiasisRenal and urinary disorders0/280/441/45
Most frequent other events
Showing 10 of 22
Most frequent other events
EventPlaceboSemaglutide 1 mgTirzepatide 15 mg
Decreased appetiteMetabolism and nutrition disorders7/2831/4427/45
Injection site haematomaGeneral disorders12/2812/4412/45
Early satietyGeneral disorders6/2812/4416/45
DyspepsiaGastrointestinal disorders2/2814/443/45
DiarrhoeaGastrointestinal disorders6/2813/449/45
NauseaGastrointestinal disorders7/2813/4411/45
FatigueGeneral disorders2/2810/445/45
ConstipationGastrointestinal disorders0/288/446/45
EructationGastrointestinal disorders0/288/448/45
NasopharyngitisInfections and infestations3/288/447/45

Baseline characteristics

All randomized participants who received at least one dose of study drug.

Age, Categorical
Age, Categorical(Participants)Tirzepatide 15 mgSemaglutide 1 mgPlaceboTotal
<=18 years0000
Between 18 and 65 years31201869
>=65 years14241048
Age, Continuous
Age, Continuous(years)Tirzepatide 15 mgSemaglutide 1 mgPlaceboTotal
Mean61.1 ± 7.163.7 ± 5.960.4 ± 7.661.9 ± 6.9
Sex: Female, Male
Sex: Female, Male(Participants)Tirzepatide 15 mgSemaglutide 1 mgPlaceboTotal
Female1410731
Male31342186
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Tirzepatide 15 mgSemaglutide 1 mgPlaceboTotal
Hispanic or Latino0000
Not Hispanic or Latino454428117
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Tirzepatide 15 mgSemaglutide 1 mgPlaceboTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American1001
White444428116
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(Participants)Tirzepatide 15 mgSemaglutide 1 mgPlaceboTotal
Germany454428117
HbA1c (%)
HbA1c (%)(percentage)Tirzepatide 15 mgSemaglutide 1 mgPlaceboTotal
Mean7.83 ± 0.727.70 ± 0.607.90 ± 0.517.80 ± 0.63
08

Study locations

2 sites
  • Profil Institut für Stoffwechselforschung
    Neuss, North Rhine-Westphalia 41460, Germany
  • Profil Mainz GmbH & Co. KG
    Mainz, Rhineland-Palatinate 55116, Germany
09

References and documents

Publications

  • Heise T, DeVries JH, Urva S, Li J, Pratt EJ, Thomas MK, Mather KJ, Karanikas CA, Dunn J, Haupt A, Milicevic Z, Coskun T. Tirzepatide Reduces Appetite, Energy Intake, and Fat Mass in People With Type 2 Diabetes. Diabetes Care. 2023 May 1;46(5):998-1004. doi: 10.2337/dc22-1710. PubMed 36857477 ↗
  • Heise T, Mari A, DeVries JH, Urva S, Li J, Pratt EJ, Coskun T, Thomas MK, Mather KJ, Haupt A, Milicevic Z. Effects of subcutaneous tirzepatide versus placebo or semaglutide on pancreatic islet function and insulin sensitivity in adults with type 2 diabetes: a multicentre, randomised, double-blind, parallel-arm, phase 1 clinical trial. Lancet Diabetes Endocrinol. 2022 Jun;10(6):418-429. doi: 10.1016/S2213-8587(22)00085-7. Epub 2022 Apr 22. PubMed 35468322 ↗

Study documents

  • Study protocol · Jun 10, 2020
  • Statistical analysis plan · May 27, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03951753
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
May 15, 2019
Start date
Jun 28, 2019
Primary completion
Apr 8, 2021
Completion
Apr 8, 2021
Results posted
Mar 20, 2023
Last update
Mar 20, 2023

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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