Type 2 DiabetesPhase 2NCT06897475
A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
A Phase 2 study testing LY3457263 in people with Type 2 Diabetes, run by Eli Lilly and Company at 60 sites in 6 countries.
Trial summary
The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months. 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?
- LY3457263
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 60 sitesin 6 countries
- Study dates
- 28 Mar 2025to Jun 2027
- Phase
- Phase 2
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
- Have HbA1c ≥7.5% to ≤10.5% at screening
- Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening
- Have had a stable body weight for the three months prior to screening
- On stable treatment dose of one of the following incretins for at least three months prior to screening:
- Injectable semaglutide (1 and 2 milligram (mg))
- Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)
Who cannot join
- Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma
- Have a prior or planned surgical treatment for obesity
- Have any of the following cardiovascular conditions within three months prior to screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- unstable angina, or
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- hospitalization due to congestive heart failure
- Have used insulin to control blood glucose within the past year (short-term use allowed)
- Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening
- If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study
- Have taken any medications or alternative remedies for weight loss within three months prior to screening
Trial locations and contacts
60 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
60 sites in 6 countries
United States25 sites, 25 recruiting
- Recruiting
Investigators Research Group
Brownsburg, Indiana, 46112
317-852-8280
Kenneth Maynard
- Recruiting
Providence Health Partners-Center for Clinical Research
Dayton, Ohio, 45439
937-297-8994
Paul Opsahl
- Recruiting
Juno Research
Houston, Texas, 77040
713-779-5494
Damaris Vega
- Recruiting
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046
770-696-4541
Nadia Cameron, MD
- Recruiting
Physicians Research Associates
Lawrenceville, Georgia, 30046
678-252-2375
Ola Odugbesan
- Recruiting
NYC Research INC
Long Island City, New York, 11106
516-574-9232
Anastasios Manessis
- Recruiting
Southern Endocrinology Associates
Mesquite, Texas, 75149
214-693-0904
Sumana Gangi
- Recruiting
Lucas Research, Inc.
Morehead City, North Carolina, 28557
252-222-5700
Kathryn Lucas
- Recruiting
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, 73069
405-701-8999
Lisa Connery
- Recruiting
Renstar Medical Research
Ocala, Florida, 34471
352-629-5800
David Oliver
- Recruiting
Oviedo Medical Research
Oviedo, Florida, 32765
407-977-2705
Bradley Block
- Recruiting
Clinical Research of Philadelphia
Pennington, New Jersey, 08534
215-676-6696
Taher Modarressi
- Recruiting
Helios Clinical Research - Phoenix
Phoenix, Arizona, 85028
480-372-5996
David Francyk
- Recruiting
Eastside Research Associates
Redmond, Washington, 98052
425-869-6828
Chad Crystal
- Recruiting
Elite Clinical Trials
Rexburg, Idaho, 83440
208-356-8977
Brian Beesley
- Recruiting
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681
512-334-3505
Srujana Yada
- Recruiting
Wolverine Clinical Trials
Santa Ana, California, 92706
714-617-2426
Behnam Khaleghi
- Recruiting
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683
724-220-5281
Tiffany Pluto
- Recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
210-545-4900
Michelle Welch
- Recruiting
Shelby Clinical Research
Shelby, North Carolina, 28150
980-552-9230
Christian Martin
- Recruiting
Richmond University Medical Center
Staten Island, New York, 10310
Lina Leykina
- Recruiting
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
470-317-3604
Dwight Blake
- Recruiting
Texas Valley Clinical Research
Weslaco, Texas, 78596
956-431-8090
Eduardo Luna
- Recruiting
Southgate Medical Group
West Seneca, New York, 14224
716-712-1004
Brian Snyder
- Recruiting
North Georgia Clinical Research
Woodstock, Georgia, 30189
678-494-5735
Bram Wieskopf
United Kingdom10 sites, 10 recruiting
- Recruiting
FutureMeds - Birmingham
Birmingham, B21 9RY
0121 592 2050
Tehmina Ahmed
- Recruiting
Layton Medical Centre
Blackpool, FY3 7EN
441253951943
Rebecca Clark
- Recruiting
Southmead Hospital
Bristol, BS10 5NB
0117 4148125
Georgina Russell
- Recruiting
FutureMeds - Liverpool
Bromborough, CH62 6EE
01513150090
Connor McGladdery
- Recruiting
Futuremeds-Newcastle
Newcastle, NE6 1SG
William Aspinall
- Recruiting
Newquay Health Centre
Newquay, TR7 1RU
01637857903
Rutesh Patel
- Recruiting
George Eliot Hospital
Nuneaton, CV10 7DJ
02476153592
Ponnusamy Saravanan
- Recruiting
The Adam Practice
Poole, BH16 5PW
01202 339050
Patrick Moore
- Recruiting
Clifton Medical Centre
Rotherham, S65 1DA
01709363950
Matthew Capehorn
- Recruiting
Rame Group Practice
Torpoint, PL11 2TB
(0044) 1752 817900
Susan Keast
Canada9 sites, 9 recruiting
- Recruiting
Centricity Research Brampton Endocrinology
Brampton, L6S 0C6
905 595 0560
Harpreet Bajaj
- Recruiting
Ecogene-21
Chicoutimi, G7H 7K9
418-545-1252
Daniel Gaudet
- Recruiting
Winterberry Research Inc.
Hamilton, L8J 0B6
365-366-6267
Steven Zizzo
- Recruiting
Viacar Recherche Clinique
Longueuil, J4H 4B9
Genevieve Mathieu
- Recruiting
G A Research Associates
Moncton, E1G 1A7
506-852-9865
Jocelyn Cormier
- Recruiting
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3
1 (519) 344-6612
John O'Mahony
- Recruiting
Maple Leaf Research
Toronto, M5G 1K2
4164657936
Graham Smith
- Recruiting
Diabetes Heart Research Centre
Toronto, M6G 1M2
4169245871
Luis Noronha
- Recruiting
Fadia El Boreky Medicine
Waterloo, N2J 1C4
519-569-7592
Fadia El Boreky
Poland9 sites, 9 recruiting
- Recruiting
Legeartis - Poradnie Specjalistyczne
Bialystok, 15-404
48 507 18 11 18
Anna Modzelewska
- Recruiting
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, 80-546
48603790004
Monika Lukaszewicz
- Recruiting
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Krakow, 31-261
48126237122
Joanna Mirocka
- Recruiting
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, 90-338
607536360
Malgorzata Jozefowska
- Recruiting
Ekamed
Lublin, 20-718
48603787884
Ewa Skokowska
- Recruiting
Private Practice - Dr. Robert Witek
Tarnów, 33-100
48721000040
Robert Witek
- Recruiting
NBR Polska
Warsaw, 00-710
48514876203
Katarzyna Klodawska
- Recruiting
Szpital Czerniakowski
Warsaw, 00-737
4847722052
Olga Turowska
- Recruiting
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Wroclaw, 50-981
71 7210 873
Mateusz Tabin
Germany5 sites, 1 recruiting
- Completed
InnoDiab Forschung Gmbh
Essen, 45136
- Recruiting
Velocity Clinical Research, Leipzig
Leipzig, 04177
+4934126825556
Thomas Mueller
- Completed
Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
Leipzig, 04249
- Active, not recruiting
Institut für Diabetesforschung GmbH Münster
Münster, 48145
- Active, not recruiting
RED-Institut GmbH
Oldenburg, 23758
Puerto Rico2 sites, 2 recruiting
- Recruiting
Centro de Endocrinologia Alcantara Gonzalez
Bayamón, 00956
7877870933
Altagracia Alcantara-Gonzalez
- Recruiting
Mgcendo Llc
San Juan, 00921
7874842757
Martha Gomez-Cuellar
About this study
Official title: A Parallel-Group Treatment, Phase 2, Double-Blind Study of Once-Weekly Subcutaneous LY3457263 Compared to Placebo in Participants With Type 2 Diabetes Mellitus on a Stable Dose of Semaglutide or Tirzepatide Who Failed to Achieve HbA1c Goal
The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.
- Conditions
- Type 2 Diabetes
- Being tested
- LY3457263, Placebo
- Keywords
- Obesity, Overweight
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3457263Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3457263 Dose 1 | Experimental | Participants will receive LY3457263 subcutaneously (SC) Receives: Drug: LY3457263 |
| LY3457263 Dose 2 | Experimental | Participants will receive LY3457263 SC Receives: Drug: LY3457263 |
| LY3457263 Dose 3 | Experimental | Participants will receive LY3457263 SC Receives: Drug: LY3457263 |
| Placebo | Placebo comparator | Participants will receive placebo SC 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)
Measured: Baseline, Week 24
Secondary outcomes (2)
Change from Baseline in Fasting Serum Glucose
Measured: Baseline, Week 24
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start28 Mar 2025
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897475
- Sponsor's protocol ID
- 27344
- Other IDs
- 2024-520328-27-00, J1R-MC-GZFD
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- 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.