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CompletedNCT04591626AWARD-CHN3Updated May 24, 2023Results posted

A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes

A Phase 3 interventional study of Dulaglutide and Placebo in Type 2 Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 27 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
291
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this study is to evaluate the safety and efficacy of once weekly dulaglutide when added to insulin glargine, with metformin and/or acarbose in Chinese participants with type 2 diabetes mellitus.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • T2DM
  • LY2189265
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 291 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • have type 2 diabetes
  • are men or nonpregnant women aged ≥18 years at screening
  • have been treated with basal insulin glargine once daily and metformin and/or acarbose for at least 3 months prior to screening
  • doses of once daily insulin glargine and OAMs must be stable during the 3-month period prior to screening. Insulin glargine dose is considered stable when all doses during this period are within the range defined by ±20% of the most commonly used insulin glargine dose during this same period. Doses of metformin and/or acarbose are considered stable when doses are unchanged during the same period, and the doses should be in the inclusive range of the half maximum to maximum approved daily dose per the locally-approved label
  • have an HbA1c value ≥7.0% and ≤11.0% as assessed by the central laboratory at screening
  • require further insulin glargine dose increase at baseline per the TTT algorithm based on the SMBG data (FBG ≥5.6mmol/L) collected during the prior week
  • have stable weight (±5%) ≥3 months prior to screening
  • have body mass index (BMI) between ≥19.0 and ≤35.0 kg/m2 at screening

Exclusion criteria

Exclusion Criteria:

  • have type 1 diabetes (T1D)
  • have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
  • have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
  • have had any of the following CV conditions within the 2 months prior to screening: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke)
  • have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone or plan to have a gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®) during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility
  • have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening
  • for participants on metformin or metformin and acarbose, have renal disease or renal dysfunction (eGFR [CKD-EPI] \<45 mL/min/1.73 m2), as determined by the central laboratory; for participants on acarbose, have renal disease or renal dysfunction (eGFR [CKD-EPI] \<25 mL/min/1.73 m2), as determined by the central laboratory
  • have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) syndrome in the absence of known C-cell hyperplasia (the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B syndrome have a known RET mutation and the potential participant for the study is negative for the RET mutation)
  • have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
  • have serum calcitonin ≥20 pg/mL at screening, as determined by the central laboratory
  • have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease)
  • have been treated with any other antihyperglycemia regimen, other than basal insulin glargine once daily and metformin and/or acarbose, within the 3 months prior to screening or between screening and baseline
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
291 participants (actual)

Study arms

  • Experimental
    1.5 Milligrams (mg) Dulaglutide

    Participants received 1.5 mg Dulaglutide administered once weekly (QW) subcutaneously (SC) as add-on to titrated treat-to-target (TTT) dose of Insulin Glargine given SC, along with metformin and/or acarbose.

    Drug: Dulaglutide · Drug: Insulin Glargine

  • Placebo comparator
    Placebo

    Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.

    Drug: Placebo · Drug: Insulin Glargine

Interventions

  • DrugDulaglutide

    Administered SC

    Also known as: LY2189265

  • DrugPlacebo

    Administered SC

  • DrugInsulin Glargine

    Administered SC

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Oral Antihyperglycemic Medications (OAM) use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

    Time frame: Baseline, Week 28

Secondary outcomes

  1. Percentage of Participants Achieving HbA1c <7.0%

    HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Odds Ratio (OR) was determined using longitudinal logistic regression model with Baseline HbA1c value + OAM use + Treatment + Visit + Treatment\*Visit as variables.

    Time frame: Week 28

  2. Change From Baseline in Body Weight

    Change from baseline in body weight was reported here. LS mean was determined by MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

    Time frame: Baseline, Week 28

  3. Change From Baseline in Fasting Serum Glucose (FSG)

    Change from baseline in FSG was reported here. LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

    Time frame: Baseline, Week 28

  4. Percentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)

    Percentage of Participants Achieving HbA1c \<7.0% With no Weight Gain (\<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.

    Time frame: Week 28

  5. Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)

    Percentage of Participants Achieving HbA1c \<7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.

    Time frame: Week 28

  6. Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)

    Percentage of Participants Achieving HbA1c \<7.0% Without Weight Gain (\<0.1 kg) was reported here.

    Time frame: Week 28

  7. Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile

    The SMBG data was collected at the following 7 time points: Pre morning meal BG, 2-hour postprandial measurement for morning meal BG, Pre midday meal BG, 2-hour postprandial measurement for midday meal BG, Pre evening meal BG, 2-hour postprandial measurement for evening meals BG, and Bedtime BG. LS mean was determined using MMRM model with Baseline + OAM (metformin and/or acarbose) usage + HbA1c Group at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

    Time frame: Baseline, Week 28

  8. Change From Baseline in Daily Mean Insulin Glargine Doses

    LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

    Time frame: Baseline, Week 28

07

Results

Posted May 24, 2023

Participant flow

Participant flow — Overall Study
Milestone1.5 Milligrams (mg) DulaglutidePlacebo
Started144147
Received at least one dose of study drug144147
Completed134142
Not completed105
Withdrew: Adverse event40
Withdrew: Withdrawal by subject53
Withdrew: Physician decision01
Withdrew: Death01
Withdrew: Non-compliance with study drug10

Outcome measures

PrimaryChange From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Oral Antihyperglycemic Medications (OAM) use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · Percentage of HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c)
Percentage of HbA1c1.5 mg DulaglutidePlacebo
Change From Baseline in Hemoglobin A1c (HbA1c)-2.03 ± 0.076-1.08 ± 0.073
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = <0.001 · Ls mean difference: -0.95 · 95% CI -1.14 to -0.77
SecondaryPercentage of Participants Achieving HbA1c <7.0%

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Odds Ratio (OR) was determined using longitudinal logistic regression model with Baseline HbA1c value + OAM use + Treatment + Visit + Treatment\*Visit as variables.

Time frame:
Week 28
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving HbA1c <7.0%
Percentage of participants1.5 mg DulaglutidePlacebo
Percentage of Participants Achieving HbA1c <7.0%75.933.8
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Regression, Logistic · p = <0.001 · Odds ratio (or): 10.91 · 95% CI 5.35 to 22.28
SecondaryChange From Baseline in Body Weight

Change from baseline in body weight was reported here. LS mean was determined by MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · kilogram (kg)
Change From Baseline in Body Weight
kilogram (kg)1.5 mg DulaglutidePlacebo
Change From Baseline in Body Weight-0.76 ± 0.2240.42 ± 0.217
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = <0.001 · Ls mean difference: -1.18 · 95% CI -1.77 to -0.60
SecondaryChange From Baseline in Fasting Serum Glucose (FSG)

Change from baseline in FSG was reported here. LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · milligrams per deciliter (mg/dL)
Change From Baseline in Fasting Serum Glucose (FSG)
milligrams per deciliter (mg/dL)1.5 mg DulaglutidePlacebo
Change From Baseline in Fasting Serum Glucose (FSG)-58.47 ± 2.339-43.64 ± 2.269
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = <0.001 · Ls mean difference: -14.82 · 95% CI -20.57 to -9.08
SecondaryPercentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)

Percentage of Participants Achieving HbA1c \<7.0% With no Weight Gain (\<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.

Time frame:
Week 28
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)
Percentage of participants1.5 mg DulaglutidePlacebo
Percentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)51.821.1
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Regression, Logistic · p = <0.001 · Odds ratio (or): 4.58 · 95% CI 2.64 to 7.95OR was determined using Logistic Regression model with Baseline HbA1c value + OAM use + Treatment as variables.
SecondaryPercentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)

Percentage of Participants Achieving HbA1c \<7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.

Time frame:
Week 28
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)
Percentage of participants1.5 mg DulaglutidePlacebo
Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)74.833.3
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Regression, Logistic · p = <0.001 · Odds ratio (or): 7.59 · 95% CI 4.27 to 13.48OR was determined using logistic regression model: Variable = Baseline HbA1c value + OAM use + Treatment as variables.
SecondaryPercentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)

Percentage of Participants Achieving HbA1c \<7.0% Without Weight Gain (\<0.1 kg) was reported here.

Time frame:
Week 28
Reported as:
Number · Percentage of participants
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)
Percentage of participants1.5 mg DulaglutidePlacebo
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)51.821.1
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Regression, Logistic · p = <0.001 · Odds ratio (or): 4.58 · 95% CI 2.64 to 7.95OR was determined using logistic regression model with Baseline HbA1c value + OAM use + Treatment as variables.
SecondaryChange From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile

The SMBG data was collected at the following 7 time points: Pre morning meal BG, 2-hour postprandial measurement for morning meal BG, Pre midday meal BG, 2-hour postprandial measurement for midday meal BG, Pre evening meal BG, 2-hour postprandial measurement for evening meals BG, and Bedtime BG. LS mean was determined using MMRM model with Baseline + OAM (metformin and/or acarbose) usage + HbA1c Group at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · milligrams per deciliter (mg/dL)
Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile
milligrams per deciliter (mg/dL)1.5 mg DulaglutidePlacebo
Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile-64.0 ± 2.42-37.7 ± 2.36
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = <0.001 · Ls mean difference: -26.3 · 95% CI -33.0 to -19.6
SecondaryChange From Baseline in Daily Mean Insulin Glargine Doses

LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

Time frame:
Baseline, Week 28
Reported as:
Least squares mean · International Units per day(IU/day)
Change From Baseline in Daily Mean Insulin Glargine Doses
International Units per day(IU/day)1.5 mg DulaglutidePlacebo
Change From Baseline in Daily Mean Insulin Glargine Doses10.0 ± 1.04514.0 ± 1.015
Statistical analysis
  • 1.5 mg Dulaglutide vs Placebo · Mixed Models Analysis · p = 0.006 · Ls mean difference: -4.0 · 95% CI -6.86 to -1.14

Adverse events

Collected over Baseline Through End of Safety Follow-Up (Up To 32 Weeks). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1.5 mg Dulaglutide0/144 (0%)8/144 (5.6%)113/144 (78.5%)
Placebo1/147 (0.7%)12/147 (8.2%)99/147 (67.3%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
Event1.5 mg DulaglutidePlacebo
Chronic gastritisGastrointestinal disorders0/1442/147
Abdominal adhesionsGastrointestinal disorders1/1440/147
Duodenal ulcer haemorrhageGastrointestinal disorders1/1440/147
Large intestine polypGastrointestinal disorders1/1441/147
Cholecystitis acuteHepatobiliary disorders1/1440/147
CholelithiasisHepatobiliary disorders1/1440/147
AppendicitisInfections and infestations1/1440/147
Diabetes mellitus inadequate controlMetabolism and nutrition disorders1/1440/147
OsteoarthritisMusculoskeletal and connective tissue disorders1/1440/147
Cerebral infarctionNervous system disorders1/1440/147
Most frequent other events
Showing 10 of 83
Most frequent other events
Event1.5 mg DulaglutidePlacebo
Decreased appetiteMetabolism and nutrition disorders32/1446/147
Diabetic nephropathyRenal and urinary disorders20/14422/147
DiarrhoeaGastrointestinal disorders19/14412/147
NauseaGastrointestinal disorders15/1448/147
VomitingGastrointestinal disorders13/1442/147
Abdominal distensionGastrointestinal disorders11/1442/147
Upper respiratory tract infectionInfections and infestations11/14410/147
HyperglycaemiaMetabolism and nutrition disorders4/14411/147
HyperlipidaemiaMetabolism and nutrition disorders9/1447/147
DyspepsiaGastrointestinal disorders8/1441/147

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)1.5 mg DulaglutidePlaceboTotal
Mean57.80 ± 9.3358.30 ± 9.4858.10 ± 9.39
Sex: Female, Male
Sex: Female, Male(Participants)1.5 mg DulaglutidePlaceboTotal
Female5257109
Male9290182
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)1.5 mg DulaglutidePlaceboTotal
Hispanic or Latino000
Not Hispanic or Latino000
Unknown or Not Reported144147291
Race (NIH/OMB)
Race (NIH/OMB)(Participants)1.5 mg DulaglutidePlaceboTotal
American Indian or Alaska Native000
Asian144147291
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)1.5 mg DulaglutidePlaceboTotal
China144147291
Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c)(Percentage of HbA1c)1.5 mg DulaglutidePlaceboTotal
Mean8.60 ± 1.008.58 ± 0.978.59 ± 0.98
08

Study locations

27 sites
  • The Second People's Hospital of Hefei
    Hefei, Anhui 230011, China
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510120, China
  • First Affiliated Hospital of the Harbin Medical University
    Harbin, Heilongjiang 150001, China
  • The Fourth Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang 150001, China
  • The First Affiliated Hospital of Henan University of Science &Technology
    Luoyang Shi, Henan 471003, China
  • The Second Affiliated Hospital of Zhengzhou University
    Zhengzhou Shi, Henan 450014, China
  • Changzhou No.2 People's Hospital
    Changzhou, Jiangsu 213003, China
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210000, China
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210011, China
  • The First Hospital of Nanjing
    Nanjing, Jiangsu 210012, China
  • Nanjing Medical University - Nanjing Jiangning Hospital
    Nanjing, Jiangsu 211100, China
  • No. 2 Affiliated Hospital of Suzhou University
    Suzhou Shi, Jiangsu 215004, China
  • Wuxi People's Hospital
    Wuxi, Jiangsu 214023, China
  • The Third Hospital of Nanchang
    Nanchang, Jiangxi 330009, China
  • Pingxiang People's Hospital
    Pingxiang, Jiangxi 337000, China
  • The First Hospital of Jilin University
    Changchun, Jilin 130021, China
  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
    Dalian, Liaoning 116033, China
  • Jinan Central Hospital
    Jinan, Shandong 250013, China
  • Shanghai Putuo District Center Hospital
    Shanghai, Shanghai 200062, China
  • The First Affiliated Hospital of Xi'an Medical University
    XI 'an, Shanxi 710077, China
  • West China Hospital Sichuan University
    Chengdu, Sichuan 610041, China
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin 300052, China
  • The Affiliated Jiangyin Hospital of Southeast University Medical College
    Wuxi Shi, Wuxi Shi 214400, China
  • The First People's Hospital of Yunnan Province
    Kunming, Yunnan 650034, China
  • Chongqing General Hospital
    Chongqing, Yuzhong District 400014, China
  • Zhejiang Hospital
    Hangzhou, Zhejiang 310013, China
  • Beijing Pinggu District Hospital
    Beijing, 101200, China
09

References and documents

Study documents

  • Study protocol · Jul 30, 2020
  • Statistical analysis plan · Jun 29, 2022

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

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04591626
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 19, 2020
Start date
Dec 7, 2020
Primary completion
Apr 28, 2022
Completion
Apr 28, 2022
Results posted
May 24, 2023
Last update
May 24, 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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