Type 2 DiabetesPhase 2NCT04867785

A Study of LY3437943 in Participants With Type 2 Diabetes

A Phase 2 study testing LY3437943 and Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 43 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: LY3437943 and Dulaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 281 participants
Where: 43 sitesin 2 countries
Study dates: 13 May 2021to 27 Oct 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

43 sites in 2 countries.

Country

City, postcode or hospital

43 sites in 2 countries

United States40 sites

Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009
Elite Clinical Trials
Blackfoot, Idaho, 83221
Humphreys Diabetes Center
Boise, Idaho, 83702
San Fernando Valley Health Institute
Canoga Park, California, 91304
Dallas Diabetes Research Center
Dallas, Texas, 75230
Centennial Medical Group
Elkridge, Maryland, 21075
Lillestol Research
Fargo, North Dakota, 58104
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132
Valley Endocrine, Fresno
Fresno, California, 93720
The Research Center of The Upstate
Greenville, South Carolina, 29607
Endocrine Ips, Pllc
Houston, Texas, 77079
Laila A Hassan, MD, PA
Houston, Texas, 77089
National Research Institute - Huntington Park
Huntington Park, California, 90255
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Logan Health Research
Kalispell, Montana, 59901
South Florida Clinical Research Institute
Margate, Florida, 33063
Southern Endocrinology Associates
Mesquite, Texas, 75149
Catalina Research Institute, LLC
Montclair, California, 91763
Intend Research, LLC
Norman, Oklahoma, 73069
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, 76180
National Research Institute - Panorama City
Panorama City, California, 91402
MediSync Clinical Research
Petal, Mississippi, 39465
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236
Anderson Clinical Research
Redlands, California, 92374
Rainier Clinical Research Center
Renton, Washington, 98057
Elite Clinical Trials
Rexburg, Idaho, 83440
Artemis Institute for Clinical Research
Riverside, California, 92503
Artemis Institute for Clinical Research
San Diego, California, 92103
National Research Institute (NRI) - Santa Ana
Santa Ana, California, 92704
Syed Research Consultants Llc
Sheffield, Alabama, 35660
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
Clinvest Research LLC
Springfield, Missouri, 65810
Universal Research Group
Tacoma, Washington, 98405
ForCare Clinical Research
Tampa, Florida, 33613
Cotton O'Neil Clinic
Topeka, Kansas, 66606
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401
The Vancouver Clinic
Vancouver, Washington, 98664
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
Encore Medical Research - Weston
Weston, Florida, 33331

Other trials in United States

Puerto Rico3 sites

Advanced Clinical Research, LLC
Bayamón, 00961
Manati Center for Clinical Research
Manati, 674
Latin Clinical Trial Center
San Juan, 909

Other trials in Puerto Rico

About this study

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

Conditions: Type 2 Diabetes
Being tested: LY3437943, Dulaglutide, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3437943Drug
Administered SC
DulaglutideDrug
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT04867785
Study group	Role	What they receive
0.5 milligrams (mg) LY3437943	Experimental	Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW). Receives: Drug: LY3437943
4 mg LY3437943 (2 mg)	Experimental	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW. Receives: Drug: LY3437943
4 mg LY3437943 (4 mg)	Experimental	Participants received 4 mg LY3437943 administered as SC injection QW. Receives: Drug: LY3437943
8 mg LY3437943 (2 mg)	Experimental	Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW. Receives: Drug: LY3437943
8 mg LY3437943 (4 mg)	Experimental	Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW. Receives: Drug: LY3437943
12 mg LY3437943 (2 mg)	Experimental	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. Receives: Drug: LY3437943
1.5 mg Dulaglutide	Active comparator	Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW. Receives: Drug: Dulaglutide
Placebo	Placebo comparator	Participants received placebo administered as SC injection QW. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Hemoglobin A1c (HbA1c)
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.
Measured: Baseline, 24 Weeks

Secondary outcomes (9)

Change From Baseline in HbA1c
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.
Measured: Baseline, 24 Weeks
Change From Baseline in HbA1c
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.
Measured: Baseline, 36 Weeks
Percentage of Participants Reaching HbA1c <7.0%
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.
Measured: Week 24
Percentage of Participant Reaching HbA1c <7.0%
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.
Measured: Week 36
Change From Baseline in Fasting Blood Glucose (FBG)
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.
Measured: Baseline, 24 Weeks
Change From Baseline in Fasting Blood Glucose (FBG)
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.
Measured: Baseline, 36 Weeks
Change From Baseline in Body Weight
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.
Measured: Baseline, 24 Weeks
Change From Baseline in Body Weight
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.
Measured: Baseline, 36 Weeks
Population PK: Average Steady-State Plasma Concentration (Cav,ss) of LY3437943
The average steady-state plasma concentration of LY3437943 was evaluated using sparse sampling methodology/Population PK (PopPK) modeling.
Measured: Predose: Week 0, 1, 4, 12, 24, 30; Postdose: Week 2, 8, 16, 20, 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 202127 Oct 2022

First posted30 Apr 2021
Study start13 May 2021
Primary completion8 Jul 2022
Study completion27 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 281 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04867785
Sponsor's protocol ID: 17774
Other IDs: J1I-MC-GZBD
Status last verified: Jun 2023
First submitted: 29 Apr 2021
Last updated: 3 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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.

Publications

Ruotolo G, Harris C, Lin Y, Wilson JM, Pirro V, Duffin KL, Thomas MK, Hartman ML, Neill CO, Coskun T, Milicevic Z, Haupt A, Sattar N, Nicholls SJ. Retatrutide-Associated Improvements in Cardiovascular Risk Biomarkers in Adults With Obesity With or Without Type 2 Diabetes. Diabetes Obes Metab. 2026 Aug 17. doi: 10.1111/dom.71200. Online ahead of print.
PubMed 42608321
Coskun T, Wu Q, Schloot NC, Haupt A, Milicevic Z, Khouli C, Harris C. 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. Lancet Diabetes Endocrinol. 2025 Aug;13(8):674-684. doi: 10.1016/S2213-8587(25)00092-0. Epub 2025 Jun 30.
PubMed 40609566
Rosenstock J, Frias J, Jastreboff AM, Du Y, Lou J, Gurbuz S, Thomas MK, Hartman ML, Haupt A, Milicevic Z, Coskun T. 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. Lancet. 2023 Aug 12;402(10401):529-544. doi: 10.1016/S0140-6736(23)01053-X. Epub 2023 Jun 26.
PubMed 37385280

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo and Dulaglutide in Participants With Type 2 Diabetes
ClinicalTrials.gov ID: NCT04867785
Acronym / sponsor ID: 17774
Conditions: Type 2 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 281 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 13 May 2021 (actual)
Primary completion: 8 Jul 2022 (actual)
Study completion: 27 Oct 2022 (actual)
First posted: 30 Apr 2021 (actual)
Results: Posted 3 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
0.5 milligrams (mg) LY3437943	Experimental	Drug: LY3437943Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).
4 mg LY3437943 (2 mg)	Experimental	Drug: LY3437943Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
4 mg LY3437943 (4 mg)	Experimental	Drug: LY3437943Participants received 4 mg LY3437943 administered as SC injection QW.
8 mg LY3437943 (2 mg)	Experimental	Drug: LY3437943Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
8 mg LY3437943 (4 mg)	Experimental	Drug: LY3437943Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
12 mg LY3437943 (2 mg)	Experimental	Drug: LY3437943Participants 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.
1.5 mg Dulaglutide	Active comparator	Drug: DulaglutideParticipants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo administered as SC injection QW.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (10 listed)

Have type 1 diabetes mellitus (T1DM)
Have ketoacidosis
Have retinopathy, maculopathy
Have history of pancreatitis
Have obesity induced by other endocrine disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3437943Administered SC	Drug	0.5 milligrams (mg) LY3437943, 12 mg LY3437943 (2 mg), 4 mg LY3437943 (2 mg), 4 mg LY3437943 (4 mg), 8 mg LY3437943 (2 mg), 8 mg LY3437943 (4 mg)
DulaglutideAdministered SC	Drug	1.5 mg Dulaglutide
PlaceboAdministered SC	Drug	Placebo

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline, 24 Weeks
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.

9 secondary outcomes

Change From Baseline in HbA1c
Time frame: Baseline, 24 Weeks
Change From Baseline in HbA1c
Time frame: Baseline, 36 Weeks
Percentage of Participants Reaching HbA1c <7.0%
Time frame: Week 24
Percentage of Participant Reaching HbA1c <7.0%
Time frame: Week 36
Change From Baseline in Fasting Blood Glucose (FBG)
Time frame: Baseline, 24 Weeks
Change From Baseline in Fasting Blood Glucose (FBG)
Time frame: Baseline, 36 Weeks
Change From Baseline in Body Weight
Time frame: Baseline, 24 Weeks
Change From Baseline in Body Weight
Time frame: Baseline, 36 Weeks
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

Results and safety

Results posted to the registry on 3 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	45	34
1.5 Milligrams (mg) Dulaglutide	46	40
0.5 mg LY3437943	47	41
4 mg LY3437943 (2 mg)	23	19
4 mg LY3437943 (4 mg)	24	21
8 mg LY3437943 (2 mg)	26	25
8 mg LY3437943 (4 mg)	24	22
12 mg LY3437943 (2 mg)	46	35

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame: Baseline, 24 Weeks. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	Placebo n = 45	1.5 mg Dulaglutide n = 46	0.5 mg LY3437943 n = 46	4 mg LY3437943 (2 mg) n = 22	4 mg LY3437943 (4 mg) n = 24	8 mg LY3437943 (2 mg) n = 25	8 mg LY3437943 (4 mg) n = 24	12 mg LY3437943 (2 mg) n = 43
Value	-0.05 (0.21)	-1.41 (0.12)	-0.43 (0.20)	-1.39 (0.14)	-1.30 (0.22)	-1.99 (0.15)	-1.88 (0.21)	-2.01 (0.11)

Placebo vs 0.5 mg LY3437943: Least Squares (LS) Mean Difference: -0.38 (95% CI -0.94 to 0.18), p = 0.188, Mixed Models Analysis
Placebo vs 4 mg LY3437943 (2 mg): LSMean Difference: -1.34 (95% CI -1.84 to -0.85), p <0.001, Mixed Models Analysis
Placebo vs 4 mg LY3437943 (4 mg): LSMean Difference: -1.25 (95% CI -1.85 to -0.65), p <0.001, Mixed Models Analysis

Population analysed: All randomized participants with baseline and post-baseline value at the specified time point excluding participants discontinuing study drug due to inadvertent enrollment and data after permanent discontinuation of study drug or initiation of rescue medication.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Through Study Completion (Up to 280 Days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 45 (6.7%)	15 of 45 (33.3%)	0 of 45
1.5 Milligram (mg) Dulaglutide	1 of 46 (2.2%)	24 of 46 (52.2%)	0 of 46
0.5 mg LY3437943	3 of 47 (6.4%)	15 of 47 (31.9%)	0 of 47
4 mg LY3437943 (2 mg)	1 of 23 (4.3%)	9 of 23 (39.1%)	0 of 23
4 mg LY3437943 (4 mg)	2 of 24 (8.3%)	17 of 24 (70.8%)	0 of 24
8 mg LY3437943 (2 mg)	2 of 26 (7.7%)	16 of 26 (61.5%)	0 of 26
8 mg LY3437943 (4 mg)	1 of 24 (4.2%)	15 of 24 (62.5%)	0 of 24
12 mg LY3437943 (2 mg)	2 of 46 (4.3%)	25 of 46 (54.3%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42608321Ruotolo G, Harris C, Lin Y, Wilson JM, Pirro V, Duffin KL, Thomas MK, Hartman ML, Neill CO, Coskun T, Milicevic Z, Haupt A, Sattar N, Nicholls SJ. Retatrutide-Associated Improvements in Cardiovascular Risk Biomarkers in Adults With Obesity With or Without Type 2 Diabetes. Diabetes Obes Metab. 2026 Aug 17. doi: 10.1111/dom.71200. Online ahead of print.
Derived from this study: PubMed 40609566Coskun T, Wu Q, Schloot NC, Haupt A, Milicevic Z, Khouli C, Harris C. 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. Lancet Diabetes Endocrinol. 2025 Aug;13(8):674-684. doi: 10.1016/S2213-8587(25)00092-0. Epub 2025 Jun 30.
Derived from this study: PubMed 37385280Rosenstock J, Frias J, Jastreboff AM, Du Y, Lou J, Gurbuz S, Thomas MK, Hartman ML, Haupt A, Milicevic Z, Coskun T. 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. Lancet. 2023 Aug 12;402(10401):529-544. doi: 10.1016/S0140-6736(23)01053-X. Epub 2023 Jun 26.
A Study of LY3437943 in Participants With Type 2 DiabetesLink provided by the sponsor.
Individual participant dataSharing planned: 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.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

43 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3437943 and Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 43 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04867785, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.