Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of LY3437943 in Participants With Type 2 Diabetes

NCTNCT04867785Other id17774Other idJ1I-MC-GZBD

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 281 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 2 countries
United States, Puerto Rico
Start: 13 May 2021
Primary completion: 8 Jul 2022
Completion: 27 Oct 2022
First posted: 30 Apr 2021
Last update posted: 3 Jul 2023
Conditions: Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 2
A Study of LY3437943 in Participants With Type 2 Diabetes
NCT04867785
13 May 2021 to 27 Oct 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.

Interventions

LY3437943Drug
DulaglutideDrug
PlaceboDrug

Arms8

Experimental
0.5 milligrams (mg) LY3437943
Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).
Experimental
4 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
Experimental
4 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 administered as SC injection QW.
Experimental
8 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
Experimental
8 mg LY3437943 (4 mg)
Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
Experimental
12 mg LY3437943 (2 mg)
Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW.
Active comparator
1.5 mg Dulaglutide
Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
Placebo comparator
Placebo
Participants received placebo administered as SC injection QW.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, 24 Weeks
Registry description
Change in HbA1c (%) from baseline in LY3437943 relative to placebo. HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.

Secondary outcomes(9)

Change From Baseline in HbA1c
Time frame · Baseline, 24 Weeks
Registry description
Change in HbA1c (%) from baseline in LY3437943 relative to dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Change From Baseline in HbA1c
Time frame · Baseline, 36 Weeks
Registry description
Change in HbA1c (%) from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline Body Mass Index (BMI) Group (\<30 kilograms/square meter (kg/m2), \>=30 kg/m2)\*Time + Baseline\*Time.
Percentage of Participants Reaching HbA1c <7.0%
Time frame · Week 24
Registry description
Percentage of participants reaching HbA1c \<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<30 kg/m2, ≥30 kg/m2\] as fixed effects, and baseline HbA1c value as a covariate.
Percentage of Participant Reaching HbA1c <7.0%
Time frame · Week 36
Registry description
Percentage of participants reaching HbA1c \<7.0% in LY3437943 relative to placebo and dulaglutide. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<30 kg/m2, ≥30 kg/m2\] as fixed effects, and baseline HbA1c value as a covariate.
Change From Baseline in Fasting Blood Glucose (FBG)
Time frame · Baseline, 24 Weeks
Registry description
Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Change From Baseline in Fasting Blood Glucose (FBG)
Time frame · Baseline, 36 Weeks
Registry description
Change in FBG from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline BMI Group (\<30kg/m2, \>=30kg/m2)\*Time + Baseline\*Time.
Change From Baseline in Body Weight
Time frame · Baseline, 24 Weeks
Registry description
Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Strata\*Time + Baseline\*Time.
Change From Baseline in Body Weight
Time frame · Baseline, 36 Weeks
Registry description
Change in body weight from baseline in LY3437943 relative to placebo and dulaglutide. LSMean was calculated using MMRM for post-baseline measures: Variable = Treatment\*Time + Baseline HbA1c Group (\<=8.5%, \>8.5%)\*Time + Baseline BMI Group (\<30kg/m2, \>=30kg/m2)\*Time + Baseline\*Time.
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
Registry description
The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, 24 Weeks

Change From Baseline in Hemoglobin A1c (HbA1c)

Group	Value (percentage of HbA1c)	Spread
Placebo	-0.05	0.21
1.5 mg Dulaglutide	-1.41	0.12
0.5 mg LY3437943	-0.43	0.20
4 mg LY3437943 (2 mg)	-1.39	0.14
4 mg LY3437943 (4 mg)	-1.30	0.22
8 mg LY3437943 (2 mg)	-1.99	0.15
8 mg LY3437943 (4 mg)	-1.88	0.21
12 mg LY3437943 (2 mg)	-2.01	0.11

Secondary and other outcome results(7)

Secondary outcomeLeast squares mean· Baseline, 24 Weeks

Change From Baseline in HbA1c

Group	Value (percentage of HbA1c)	Spread
Placebo	-0.05	0.21
1.5 Milligram (mg) Dulaglutide	-1.41	0.12
0.5 mg LY3437943	-0.43	0.20
4 mg LY3437943 (2 mg)	-1.39	0.14
4 mg LY3437943 (4 mg)	-1.30	0.22
8 mg LY3437943 (2 mg)	-1.99	0.15
8 mg LY3437943 (4 mg)	-1.88	0.21
12 mg LY3437943 (2 mg)	-2.01	0.11

Secondary outcomeLeast squares mean· Baseline, 36 Weeks

Change From Baseline in HbA1c

Group	Value (percentage of HbA1c)	Spread
Placebo	-0.30	0.24
1.5 Milligram (mg) Dulaglutide	-1.36	0.13
0.5 mg LY3437943	-0.54	0.20
4 mg LY3437943 (2 mg)	-1.30	0.20
4 mg LY3437943 (4 mg)	-1.50	0.19
8 mg LY3437943 (2 mg)	-2.13	0.17
8 mg LY3437943 (4 mg)	-1.93	0.22
12 mg LY3437943 (2 mg)	-2.16	0.13

Secondary outcomeNumber· Week 24

Percentage of Participants Reaching HbA1c <7.0%

Group	Value (percentage of participants)
Placebo	18
1.5 Milligram (mg) Dulaglutide	52
0.5 mg LY3437943	32
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

Secondary outcomeNumber· Week 36

Percentage of Participant Reaching HbA1c <7.0%

Group	Value (percentage of participants)
Placebo	22
1.5 Milligram (mg) Dulaglutide	60
0.5 mg LY3437943	37
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

Secondary outcomeLeast squares mean· Baseline, 24 Weeks

Change From Baseline in Fasting Blood Glucose (FBG)

Group	Value (milligrams/deciliter (mg/dL))	Spread
Placebo	-10.59	5.98
1.5 Milligram (mg) Dulaglutide	-46.26	4.35
0.5 mg LY3437943	-12.71	6.95
4 mg LY3437943 (2 mg)	-30.19	12.65
4 mg LY3437943 (4 mg)	-43.89	8.42
8 mg LY3437943 (2 mg)	-66.09	3.70
8 mg LY3437943 (4 mg)	-39.80	10.79
12 mg LY3437943 (2 mg)	-65.20	4.38

Secondary outcomeLeast squares mean· Baseline, 36 Weeks

Change From Baseline in Fasting Blood Glucose (FBG)

Group	Value (mg/dL)	Spread
Placebo	-17.26	10.87
1.5 Milligram (mg) Dulaglutide	-27.53	9.07
0.5 mg LY3437943	-17.51	5.59
4 mg LY3437943 (2 mg)	-21.46	12.54
4 mg LY3437943 (4 mg)	-38.72	10.81
8 mg LY3437943 (2 mg)	-69.10	4.68
8 mg LY3437943 (4 mg)	-41.20	14.43
12 mg LY3437943 (2 mg)	-67.84	4.79

Secondary outcomeLeast squares mean· Baseline, 24 Weeks

Change From Baseline in Body Weight

Group	Value (kilograms (kg))	Spread
Placebo	-1.86	0.66
1.5 Milligram (mg) Dulaglutide	-1.16	0.63
0.5 mg LY3437943	-2.35	0.48
4 mg LY3437943 (2 mg)	-6.27	0.94
4 mg LY3437943 (4 mg)	-8.64	1.23
8 mg LY3437943 (2 mg)	-11.99	0.84
8 mg LY3437943 (4 mg)	-13.91	1.38
12 mg LY3437943 (2 mg)	-12.84	0.93

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboParticipants received placebo administered as SC injection QW.	0 / 45	3 / 45	15 / 45
1.5 Milligram (mg) DulaglutideParticipants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.	0 / 46	1 / 46	24 / 46
0.5 mg LY3437943Participants received 0.5 mg LY3437943 administered as SC injection QW.	0 / 47	3 / 47	15 / 47
4 mg LY3437943 (2 mg)Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.	0 / 23	1 / 23	9 / 23
4 mg LY3437943 (4 mg)Participants received 4 mg LY3437943 administered as SC injection QW.	0 / 24	2 / 24	17 / 24
8 mg LY3437943 (2 mg)Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.	0 / 26	2 / 26	16 / 26
8 mg LY3437943 (4 mg)Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as SC injection QW.	0 / 24	1 / 24	15 / 24
12 mg LY3437943 (2 mg)Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as SC injection QW.	0 / 46	2 / 46	25 / 46

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2026

11 results

Retatrutide-Associated Improvements in Cardiovascular Risk Biomarkers in Adults With Obesity With or Without Type 2 Diabetes.

Ruotolo et al. 2026Diabetes, obesity & metabolismcited by 1

PMID 42608321PMC13646367DOI 10.1111/dom.71200PUB-42608321

Free to read · publisher termsCC BY-NC11 results

Read at source See results (11)

Indexing hint: Randomized controlled trial · 2025

18 results

Effects of retatrutide on body composition in people with type 2 diabetes: a substudy of a phase 2, double-blind, parallel-group, placebo-controlled, randomised trial.

Coskun et al. 2025The lancet. Diabetes & endocrinologycited by 39

PMID 40609566DOI 10.1016/s2213-8587(25)00092-0PUB-40609566

Full text at the publisher18 results

Publisher page See results (18)

Indexing hint: Randomized controlled trial · 2023

31 results

Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA.

Rosenstock et al. 2023Lancet (London, England)cited by 309

PMID 37385280DOI 10.1016/s0140-6736(23)01053-xPUB-37385280

Full text at the publisher31 results

Publisher page See results (31)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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