A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5)

Start 22 Oct 2024 · Status Ongoing, recruitment ended · 2 EU/EEA countries · 20 sites · Protocol J1I-MC-GZBP

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 850

Countries 2

Sites 20

Obesity

To demonstrate that retatrutide MTD is superior to tirzepatide MTD for change in body weight.

Key facts

Sponsor: Eli Lilly & Co.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trial duration: 22 Oct 2024 → ongoing
Decision date (initial): 2024-09-20
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2024-511450-49-00
WHO UTN: U1111-1307-7971

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To demonstrate that retatrutide MTD is superior to tirzepatide MTD for change in body weight.

Conditions and MedDRA coding

Obesity

Regulatory references

Scientific advice from competent authorities: European Medicines Agency
Plan to share IPD: Yes

EU CT number	Title	Sponsor
2023-508630-34-00	J1I-MC-GZBO: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease.	Eli Lilly & Co.
2023-507846-96-00	I8F-MC-GPGN: The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)	Eli Lilly & Co.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight

Exclusion criteria 6

Have had the following within 90 days before screening: heart attack, stroke, revascularization, hospitalization for congestive heart failure or unstable angina
Have been taking any weight loss drugs, including over-the-counter medications, within 90 days before screening
Have had a change in body weight greater than 11 pounds within 90 days before screening
Have or are planning a surgical treatment for obesity
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Have had pancreatitis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Percent Change from Baseline in Body Weight

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Retatrutide

PRD10345188 · Product

Active substance: LY3437943 Sodium
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

Retatrutide

PRD10345489 · Product

Active substance: LY3437943 Sodium
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

Retatrutide

PRD10345508 · Product

Active substance: LY3437943 Sodium
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

Retatrutide

PRD10345209 · Product

Active substance: LY3437943 Sodium
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

Retatrutide

PRD10345551 · Product

Active substance: LY3437943 Sodium
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

Comparator 6

Tirzepatide

PRD7107378 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107375 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107376 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107379 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107377 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107380 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: SUBCUTANEOUS INJECTION
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 80 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

Sponsor organisation: Eli Lilly & Co.
Address: 1 Lilly Corporate Center
City: Indianapolis
Postcode: 46285-0001
Country: United States

Scientific contact point

Organisation: Eli Lilly & Co.
Contact name: Lilly Clinical Trials information desk

Public contact point

Organisation: Eli Lilly & Co.
Contact name: Lilly Clinical Trials information desk

Third parties 16

Organisation	City, country	Duties
Greenphire LLC ORG-100041621	King Of Prussia, United States	Other
Iqvia Rds Inc. ORG-100043858	Durham, United States	On site monitoring
Yprime LLC ORG-100042888	Malvern, United States	E-data capture
Brightech International LLC ORL-000002985	Somerset, New Jersey, United States	Code 10
Clinical Trial Media Inc. ORG-100046339	Hauppauge, United States	Other
Bioagilytix Labs LLC ORG-100013030	Durham, United States	Laboratory analysis
IQVIA Uk Ltd ( IQVIA Connected Devices) ORL-000008559	Durham North Carolina, United States	Other
Q2 Solutions LLC ORG-100017000	Ithaca, United States	Laboratory analysis
Clariness GmbH ORG-100045306	Hamburg, Germany	Other
Icon Clinical Research Limited ORG-100008322	Dublin 18, Ireland	Other
Cleveland Clinic Foundation ORG-100028017	Cleveland, United States	Other
RWS Life Sciences Inc. ORG-100042348	East Hartford, United States	Data management
R&G US Inc ORL-000008558	Somerset New Jersey, United States	Code 10
Techdata Service Company LLC ORG-100047422	Kng Of Prussa, United States	Code 10
Labcorp Central Laboratory Services SARL ORG-100011524	Meyrin, Switzerland	Other
Biotel Research LLC ORG-100039864	Rochester, United States	Other

Locations

2 EU/EEA countries · 20 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ongoing, recruitment ended	80	9
Poland	Ongoing, recruitment ended	145	11
Rest of world United States, Argentina	—	625	—

Investigational sites

Germany

9 sites · Ongoing, recruitment ended

Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob

N/A, Brombeerweg 6, 78048, Villingen-Schweningen

Diabetes-Zentrum-Wilhelmsburg GbR

N/A, Krieterstrasse 30, Wilhelmsburg, Hamburg

RED Oncology GmbH

N/A, Markt 15, 23758, Oldenburg In Holstein

Zentrum fur klinische Forschung - Köln

N/A, Berliner Strasse 895, 1. OG, Köln

Medizentrum Essen Borbeck

N/A, Huelsmannstrasse 6, Borbeck, Essen

Diabeteszentrum Hamburg West

N/A, Beselerstrasse 2a, 22607, Hamburg

Ambenet GmbH Das Ambulante Behandlungsnetz

N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig

Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz

N/A, Am Wall Süd 20, 49808, Lingen

InnoDiab Forschung GmbH

N/A, Eleonorastrasse 42, Ruettenscheid, Essen

Poland

11 sites · Ongoing, recruitment ended

Ekamed Sp. z o.o.

NA, Aleja Krasnicka 2j/u1, 20-718, Lublin

Centrum Terapii Współczesnej

NA, Ul. Przedzalniana 66, 90-338, Lodz

NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny

NA, Ul. Ludwika Zamenhofa 10/20, 15-435, Bialystok

Gabinet Leczenia Otylosci i Chorob Dietozaleznych

NA, ul. Legionowa 9A, 15-281, Bialystok

NZOZ Neuro-Kard "Ilkowski i Partnerzy" Spółka Partnerska Lekarzy

NA, ul. Wierzbowa 2/2, 61-853, Poznań

Uniwersytecki Szpital Kliniczny W Bialymstoku

Klinika Endokrynologii, Diabetologii I Chorób Wewnętrznych, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok

Zdrowie Osteo-Medic SC.

NA, Wiejska 81, 15-351, Bialystok

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

NA, Ul.Niedurnego 50D, 41-709, Ruda Slaska

Uniwersytecki Szpital Kliniczny W Bialymstoku

Centrum Badań Klinicznych, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok

Centrum Zdrowia Metabolicznego

NA, ul. Nowina 14 F, 60-589, Poznań

Terpa Sp. z o.o. sp.k.

NA, Ul. Pogodna 34, 20-333, Lublin

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2024-10-22		2024-11-01	2025-04-07
Poland	2024-10-23		2024-11-04	2025-04-07

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 34 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol 2024-511450-49-00_Redacted	c
Protocol (for publication)	D4_Patient facing documents_copyright	1.0
Recruitment arrangements (for publication)	K1_Recruitment Arrangements_GZBP	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements_PL	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements_recruitment arrangements statement	1
Recruitment arrangements (for publication)	K2_recruitment material_ list of appreciation items	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_CWM_Master_PL	3
Recruitment arrangements (for publication)	K2_Recruitment material_CWM_Program_Database_Messaging_PL	4
Recruitment arrangements (for publication)	K2_Recruitment material_CWM_Program_Website_PL	3
Recruitment arrangements (for publication)	K2_Recruitment material_CWM_Program_Website_Policies_PL	1
Recruitment arrangements (for publication)	K2_Recruitment material_CWM_Screener_PL	6
Recruitment arrangements (for publication)	K2_Recruitment material_GZBP_Patient_Messaging_PL	1
Recruitment arrangements (for publication)	K2_Recruitment material_GZBP_Website_Copy_PL	1
Recruitment arrangements (for publication)	K2_Recruitment material_Recruitment Poster_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment materials_Clariness recruitment material	1.0
Recruitment arrangements (for publication)	K2_Recruitment materials_Poster_DE_Redacted	1.0
Recruitment arrangements (for publication)	K3_List of planned sites_Poland	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Confidentiality Notice for TLC	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_PL_Redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_Redacted	6
Subject information and informed consent form (for publication)	L2_Other subject information material_Emergency Card GZBP_PL	1
Subject information and informed consent form (for publication)	L2_Other subject information material_IFU_Redacted	1
Subject information and informed consent form (for publication)	L2_Other subject information material_study guide_DE_Redacted	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Study Guide_Redacted	3
Subject information and informed consent form (for publication)	L2_Other subject information material_ZoomHealth_PrivacyStatement	1
Subject information and informed consent form (for publication)	L2_Other subject information material_ZoomHealth_Screenshots	1
Subject information and informed consent form (for publication)	L2_Other subject information material_ZoomHealth_TermsofService	1
Subject information and informed consent form (for publication)	L2_SIS and ICF_Patient cards	1.0
Subject information and informed consent form (for publication)	L3_GZBP_Instructions for Use_Germany_Redacted	1.0
Subject information and informed consent form (for publication)	L3_Info Re insurance Conditions for Patient	1
Subject information and informed consent form (for publication)	L4_Informed consent and patient recruitment procedure_PL	1
Subject information and informed consent form (for publication)	L5_Confidentiality Notice_PL	2
Synopsis of the protocol (for publication)	D1_Protocol synopsis EN 2024-511450-49-00_Redacted	c
Synopsis of the protocol (for publication)	D1_Protocol synopsis PL_2024-511450-49-00_Redacted	1.0

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-06-19	Germany	Acceptable 2024-09-19	2024-09-20
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2024-10-11	Germany	Acceptable 2024-09-19	2024-10-11
3	SUBSTANTIAL MODIFICATION	SM-1	2024-11-14		Acceptable	2025-01-10
4	SUBSTANTIAL MODIFICATION	SM-2	2025-03-14	Germany	Acceptable 2025-04-24	2025-04-29
5	NON SUBSTANTIAL MODIFICATION	NSM-2	2025-07-03	Germany	Acceptable 2025-04-24	2025-07-03
6	NON SUBSTANTIAL MODIFICATION	NSM-3	2025-11-28	Germany	Acceptable 2025-04-24	2025-11-28

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5)

Overview

Key facts

External identifiers

Trial design

Main objective

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 1

Exclusion criteria 6

Endpoints

Primary endpoints 1

Investigational products

Test 5

Comparator 6

Sponsors and contacts

Eli Lilly & Co.

Scientific contact point

Public contact point

Third parties 16

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 34 files

Application history

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