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CompletedPhase 2Results posted

A Study of LY3437943 in Participants With Type 2 Diabetes

A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes

Assets

Dulaglutide / Retatrutide

Listed sites

43

Recruiting sites

Enrollment

281

actual

Study population

Type 2 diabetes

Key I/E criterion

HbA1c 7-10.5%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04867785
Org study ID17774
Secondary IDJ1I-MC-GZBDEli Lilly and Company

Timeline

Milestones

Study first posted2021-04-30actual
Study start2021-05-13actual
Primary completion2022-07-08actual
Study completion2022-10-27actual
Last update posted2023-07-03actual
Results first posted2023-07-03actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have Type 2 Diabetes (T2D)
Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening.

Exclusion criteria

Have type 1 diabetes mellitus (T1DM)
Have ketoacidosis
Have retinopathy, maculopathy
Have history of pancreatitis
Have obesity induced by other endocrine disorders
Have uncontrolled hypertension
Have acute or chronic hepatitis
Have chronic kidney disease
Have an autoimmune abnormality for example, lupus or rheumatoid arthritis
Have an active or untreated malignancy

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
14
Weight & body composition
4
Safety / tolerability / PK
2

Weight & body composition

4 endpoints
Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, 24 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilograms (kg)95% CI
Placebo-1.86
1.5 Milligram (mg) Dulaglutide-1.16
0.5 mg LY3437943-2.35
4 mg LY3437943 (2 mg)-6.27
4 mg LY3437943 (4 mg)-8.64
8 mg LY3437943 (2 mg)-11.99
8 mg LY3437943 (4 mg)-13.91
12 mg LY3437943 (2 mg)-12.84
LSMean Difference-0.4995% CI-2.071.08p0.540Mixed Models Analysis
LSMean Difference-4.4195% CI-6.69-2.13p<0.001Mixed Models Analysis
LSMean Difference-6.7895% CI-9.47-4.09p<0.001Mixed Models Analysis
LSMean Difference-10.1395% CI-12.24-8.03p<0.001Mixed Models Analysis
LSMean Difference-12.0695% CI-15.06-9.06p<0.001Mixed Models Analysis
LSMean Difference-10.9995% CI-13.24-8.73p<0.001Mixed Models Analysis
LSMean Difference-1.1995% CI-2.750.37p0.135Mixed Models Analysis
LSMean Difference-5.1195% CI-7.36-2.86p<0.001Mixed Models Analysis
LSMean Difference-7.4895% CI-10.19-4.77p<0.001Mixed Models Analysis
LSMean Difference-10.8395% CI-12.89-8.77p<0.001Mixed Models Analysis
LSMean Difference-12.7695% CI-15.74-9.77p<0.001Mixed Models Analysis
LSMean Difference-11.6995% CI-13.90-9.47p<0.001Mixed Models Analysis
Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, 36 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilograms (kg)95% CI
Placebo-3.28
1.5 Milligram (mg) Dulaglutide-1.97
0.5 mg LY3437943-3.31
4 mg LY3437943 (2 mg)-7.28
4 mg LY3437943 (4 mg)-10.37
8 mg LY3437943 (2 mg)-16.48
8 mg LY3437943 (4 mg)-16.12
12 mg LY3437943 (2 mg)-17.18
LSMean Difference-0.0395% CI-2.182.12p0.979Mixed Models Analysis
LSMean Difference-4.0095% CI-7.32-0.68p0.018Mixed Models Analysis
LSMean Difference-7.0995% CI-10.46-3.71p<0.001Mixed Models Analysis
LSMean Difference-13.2095% CI-16.74-9.66p<0.001Mixed Models Analysis
LSMean Difference-12.8495% CI-16.50-9.18p<0.001Mixed Models Analysis
LSMean Difference-13.9195% CI-17.10-10.71p<0.001Mixed Models Analysis
LSMean Difference-1.3495% CI-3.450.77p0.213Mixed Models Analysis
LSMean Difference-5.3195% CI-8.66-1.97p0.002Mixed Models Analysis
LSMean Difference-8.4095% CI-11.76-5.04p<0.001Mixed Models Analysis
LSMean Difference-14.5195% CI-18.00-11.01p<0.001Mixed Models Analysis
LSMean Difference-14.1595% CI-17.77-10.54p<0.001Mixed Models Analysis
LSMean Difference-15.2295% CI-18.36-12.07p<0.001Mixed Models Analysis
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, 24 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, 36 Weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

14 endpoints
Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, 24 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of HbA1c95% CI
Placebo-0.05
1.5 mg Dulaglutide-1.41
0.5 mg LY3437943-0.43
4 mg LY3437943 (2 mg)-1.39
4 mg LY3437943 (4 mg)-1.30
8 mg LY3437943 (2 mg)-1.99
8 mg LY3437943 (4 mg)-1.88
12 mg LY3437943 (2 mg)-2.01
Least Squares (LS) Mean Difference-0.3895% CI-0.940.18p0.188Mixed Models Analysis
LSMean Difference-1.3495% CI-1.84-0.85p<0.001Mixed Models Analysis
LSMean Difference-1.2595% CI-1.85-0.65p<0.001Mixed Models Analysis
LSMean Difference-1.9495% CI-2.44-1.43p<0.001Mixed Models Analysis
LSMean Difference-1.8395% CI-2.42-1.24p<0.001Mixed Models Analysis
LSMean Difference-1.9695% CI-2.43-1.50p<0.001Mixed Models Analysis
Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, 24 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in HbA1c

Time frame:Baseline, 24 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of HbA1c95% CI
Placebo-0.05
1.5 Milligram (mg) Dulaglutide-1.41
0.5 mg LY3437943-0.43
4 mg LY3437943 (2 mg)-1.39
4 mg LY3437943 (4 mg)-1.30
8 mg LY3437943 (2 mg)-1.99
8 mg LY3437943 (4 mg)-1.88
12 mg LY3437943 (2 mg)-2.01
LSMean Difference0.9895% CI0.521.43p<0.001Mixed Models Analysis
LSMean Difference0.0195% CI-0.340.37p0.935Mixed Models Analysis
LSMean Difference0.1195% CI-0.390.60p0.668Mixed Models Analysis
LSMean Difference-0.5895% CI-0.95-0.21p0.002Mixed Models Analysis
LSMean Difference-0.4795% CI-0.950.01p0.056Mixed Models Analysis
LSMean Difference-0.6195% CI-0.93-0.29p<0.001Mixed Models Analysis
Secondary/registry result

Change From Baseline in HbA1c

Time frame:Baseline, 36 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of HbA1c95% CI
Placebo-0.30
1.5 Milligram (mg) Dulaglutide-1.36
0.5 mg LY3437943-0.54
4 mg LY3437943 (2 mg)-1.30
4 mg LY3437943 (4 mg)-1.50
8 mg LY3437943 (2 mg)-2.13
8 mg LY3437943 (4 mg)-1.93
12 mg LY3437943 (2 mg)-2.16
LSMean Difference-0.2495% CI-0.850.38p0.448Mixed Models Analysis
LSMean Difference-0.9995% CI-1.60-0.38p0.001Mixed Models Analysis
LSMean Difference-1.2095% CI-1.80-0.59p<0.001Mixed Models Analysis
LSMean Difference-1.8395% CI-2.41-1.24p<0.001Mixed Models Analysis
LSMean Difference-1.6395% CI-2.27-0.99p<0.001Mixed Models Analysis
LSMean Difference-1.8595% CI-2.39-1.31p<0.001Mixed Models Analysis
LSMean Difference0.8295% CI0.351.29p<0.001Mixed Models Analysis
LSMean Difference0.0695% CI-0.410.53p0.796Mixed Models Analysis
LSMean Difference-0.1495% CI-0.610.32p0.548Mixed Models Analysis
LSMean Difference-0.7795% CI-1.19-0.36p<0.001Mixed Models Analysis
LSMean Difference-0.5795% CI-1.08-0.07p0.025Mixed Models Analysis
LSMean Difference-0.8095% CI-1.16-0.44p<0.001Mixed Models Analysis
Secondary/registry result

Percentage of Participants Reaching HbA1c <7.0%

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Placebo18
1.5 Milligram (mg) Dulaglutide52
0.5 mg LY343794332
4 mg LY3437943 (2 mg)53
4 mg LY3437943 (4 mg)66
8 mg LY3437943 (2 mg)88
8 mg LY3437943 (4 mg)78
12 mg LY3437943 (2 mg)86
Risk Difference (RD)0.1495% CI-0.040.32p0.121Regression, Logistic
Risk Difference (RD)0.3695% CI0.130.59p0.002Regression, Logistic
Risk Difference (RD)0.4895% CI0.280.68p<0.001Regression, Logistic
Risk Difference (RD)0.7095% CI0.530.87p<0.001Regression, Logistic
Risk Difference (RD)0.6095% CI0.390.82p<0.001Regression, Logistic
Risk Difference (RD)0.6895% CI0.510.85p<0.001Regression, Logistic
Risk Difference (RD)-0.2195% CI-0.39-0.02p0.030Regression, Logistic
Risk Difference (RD)0.0195% CI-0.220.24p0.938Regression, Logistic
Risk Difference (RD)0.1395% CI-0.070.33p0.209Regression, Logistic
Risk Difference (RD)0.3595% CI0.180.53p<0.001Regression, Logistic
Risk Difference (RD)0.2695% CI0.030.48p0.024Regression, Logistic
Risk Difference (RD)0.3395% CI0.160.51p<0.001Regression, Logistic
Secondary/registry result

Percentage of Participant Reaching HbA1c <7.0%

Time frame:Week 36

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Placebo22
1.5 Milligram (mg) Dulaglutide60
0.5 mg LY343794337
4 mg LY3437943 (2 mg)61
4 mg LY3437943 (4 mg)59
8 mg LY3437943 (2 mg)82
8 mg LY3437943 (4 mg)78
12 mg LY3437943 (2 mg)80
Risk Difference (RD)0.1495% CI-0.060.35p0.169Regression, Logistic
Risk Difference (RD)0.3995% CI0.150.63p0.001Regression, Logistic
Risk Difference (RD)0.3795% CI0.140.60p0.002Regression, Logistic
Risk Difference (RD)0.5995% CI0.390.79p<0.001Regression, Logistic
Risk Difference (RD)0.5695% CI0.340.78p<0.001Regression, Logistic
Risk Difference (RD)0.5795% CI0.380.76p<0.001Regression, Logistic
Risk Difference (RD)-0.2395% CI-0.44-0.02p0.029Regression, Logistic
Risk Difference (RD)0.0295% CI-0.220.25p0.898Regression, Logistic
Risk Difference (RD)0.0095% CI-0.240.23p0.968Regression, Logistic
Risk Difference (RD)0.2295% CI0.020.42p0.033Regression, Logistic
Risk Difference (RD)0.1995% CI-0.040.41p0.099Regression, Logistic
Risk Difference (RD)0.2095% CI0.010.39p0.044Regression, Logistic
Secondary/registry result

Change From Baseline in Fasting Blood Glucose (FBG)

Time frame:Baseline, 24 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), milligrams/deciliter (mg/dL)95% CI
Placebo-10.59
1.5 Milligram (mg) Dulaglutide-46.26
0.5 mg LY3437943-12.71
4 mg LY3437943 (2 mg)-30.19
4 mg LY3437943 (4 mg)-43.89
8 mg LY3437943 (2 mg)-66.09
8 mg LY3437943 (4 mg)-39.80
12 mg LY3437943 (2 mg)-65.20
LSMean Difference-2.1295% CI-20.7316.48p0.823Mixed Models Analysis
LSMean Difference-19.6095% CI-47.298.10p0.165Mixed Models Analysis
LSMean Difference-33.3095% CI-53.56-13.04p0.001Mixed Models Analysis
LSMean Difference-55.5095% CI-69.77-41.22p<0.001Mixed Models Analysis
LSMean Difference-29.2295% CI-52.84-5.59p0.015Mixed Models Analysis
LSMean Difference-54.6195% CI-69.63-39.59p<0.001Mixed Models Analysis
LSMean Difference33.5495% CI18.2648.82p<0.001Mixed Models Analysis
LSMean Difference16.0795% CI-10.2542.39p0.231Mixed Models Analysis
LSMean Difference2.3795% CI-16.2821.01p0.804Mixed Models Analysis
LSMean Difference-19.8395% CI-31.01-8.65p<0.001Mixed Models Analysis
LSMean Difference6.4595% CI-16.7529.65p0.586Mixed Models Analysis
LSMean Difference-18.9495% CI-30.93-6.96p0.002Mixed Models Analysis
Secondary/registry result

Change From Baseline in Fasting Blood Glucose (FBG)

Time frame:Baseline, 36 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), mg/dL95% CI
Placebo-17.26
1.5 Milligram (mg) Dulaglutide-27.53
0.5 mg LY3437943-17.51
4 mg LY3437943 (2 mg)-21.46
4 mg LY3437943 (4 mg)-38.72
8 mg LY3437943 (2 mg)-69.10
8 mg LY3437943 (4 mg)-41.20
12 mg LY3437943 (2 mg)-67.84
LSMean Difference-0.2595% CI-24.5724.07p0.984Mixed Models Analysis
LSMean Difference-4.2095% CI-37.4429.03p0.804Mixed Models Analysis
LSMean Difference-21.4795% CI-51.918.98p0.167Mixed Models Analysis
LSMean Difference-51.8495% CI-76.09-27.59p<0.001Mixed Models Analysis
LSMean Difference-23.9495% CI-57.9410.06p0.168Mixed Models Analysis
LSMean Difference-50.5895% CI-74.94-26.22p<0.001Mixed Models Analysis
LSMean Difference10.0295% CI-11.5531.60p0.362Mixed Models Analysis
LSMean Difference6.0795% CI-24.3436.48p0.696Mixed Models Analysis
LSMean Difference-11.1995% CI-39.3816.99p0.436Mixed Models Analysis
LSMean Difference-41.5795% CI-62.89-20.25p<0.001Mixed Models Analysis
LSMean Difference-13.6795% CI-46.7519.42p0.418Mixed Models Analysis
LSMean Difference-40.3195% CI-60.77-19.85p<0.001Mixed Models Analysis
Secondary/protocol endpoint

Change From Baseline in HbA1c

Time frame:Baseline, 24 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in HbA1c

Time frame:Baseline, 36 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7.0%

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participant Reaching HbA1c <7.0%

Time frame:Week 36

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose (FBG)

Time frame:Baseline, 24 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose (FBG)

Time frame:Baseline, 36 Weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

2 endpoints
Secondary/registry result

Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943

Time frame:Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupValue (number), nanograms/milliliter (ng/mL)95% CI
0.5 mg LY343794362.8
4 mg LY3437943 (2 mg)466
4 mg LY3437943 (4 mg)551
8 mg LY3437943 (2 mg)1100
8 mg LY3437943 (4 mg)1140
12 mg LY3437943 (2 mg)1620
Secondary/protocol endpoint

Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943

Time frame:Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36

Plasma concentration (steady state)

concentration, descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.