A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee (TRIUMPH-4)

2023-503660-17-00 Protocol J1I-MC-GZBN Therapeutic confirmatory (Phase III) Ended

Start 9 Oct 2023 · End 14 Nov 2025 · Status Ended · 1 EU/EEA countries · 8 sites · Protocol J1I-MC-GZBN

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 439
Countries 1
Sites 8

Overweight

- To demonstrate that LY3437943 9 mg and/or 12 mg QW is superior to placebo for: change in the WOMAC Pain subscale AND change in bodyweight.

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
9 Oct 2023 → 14 Nov 2025
Decision date (initial)
2023-09-15
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2023-503660-17-00
WHO UTN
U1111-1287-2957

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

- To demonstrate that LY3437943 9 mg and/or 12 mg QW is superior to placebo for: change in the WOMAC Pain subscale AND change in bodyweight.

Conditions and MedDRA coding

Overweight

Regulatory references

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Be overweight.
  2. Have a history of 1 self-reported unsuccessful dietary effort to lose body weight.
  3. Have knee pain prior to screening more than 12 weeks

Exclusion criteria 3

  1. Have a change in body weight greater than 11 pounds
  2. Prior joint replacement in the index knee
  3. Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
  2. Percent Change from Baseline in Body Weight

Investigational products

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

Test 5

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
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

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
1 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
1 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
1 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
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo Injection

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
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 12

OrganisationCity, countryDuties
Techdata Service Company LLC
ORG-100047422
 Kng Of Prussa, United States Code 10
IQVIA RDS (India) Private Limited
ORG-100047036
 Mumbai, India Laboratory analysis
Brightech International, LLC
ORL-000001391
 Somerset, NJ, United States Code 10
Yprime LLC
ORG-100042888
 Malvern, United States E-data capture
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Laboratory analysis
Clario
ORL-000001584
 San Mateo CA, United States Laboratory analysis
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Iqvia Rds Inc.
ORG-100043858
 Durham, United States On site monitoring
PPD Global Central Labs
ORG-100046496
 Zaventem, Belgium Laboratory analysis
Cleveland Clinic Foundation
ORG-100028017
 Cleveland, United States Other
Q2 Solutions LLC
ORG-100017000
 Ithaca, United States Laboratory analysis

Locations

1 EU/EEA country · 8 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ended 65 8
Rest of world
China, United States, Australia, Mexico, United Kingdom, Canada
 — 374 —

Investigational sites

Spain

8 sites · Ended
Area Sanitaria De Ferrol
Endocrinology, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitario Infanta Sofía
Endocrinology, Paseo De Europa 34, 28702, San Sebastian De Los Reyes
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Endocrinology and metabolism, Calle Alejo Fernandez 9, 41003, Sevilla
Hospital Quironsalud Malaga
Endocrinology and metabolism, Avenida Imperio Argentina 1, 29004, Malaga
Complexo Hospitalario Universitario A Coruna
Endocrinology and metabolism, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital De La Santa Creu I Sant Pau
AGDAC (Endocrinology and Nutrition), Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital General Universitario De Valencia
Endocrinology and metabolism, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Universitario Reina Sofia
Internal Medicin, Avenida Menendez Pidal S/n, 14004, Cordoba

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2023-10-09 2025-10-28 2023-10-16 2024-05-23

Results and documents

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

Documents 43 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol 2023-503660-17-00_Redacted b
Protocol (for publication) Patient-facing documents copyright statement 1
Recruitment arrangements (for publication) K1_Recruitment arrangements_Spain 1
Recruitment arrangements (for publication) K1_Recruitment material_Appreciation Items_Spain 2
Recruitment arrangements (for publication) K2_Recruitment materia_Program_Database_Messaging_Master_ES TC 3.1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_Spanish 1
Recruitment arrangements (for publication) K2_Recruitment material_Chronic_Weight_Social_Media_Video_Master 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Digital_Ads__Comorbidities__Master_ES TC 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Digital_Ads_Comorbidities_Master 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Digital_Ads_Comorbidities_Master_ES TC 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Digital_Ads_General_Chronic_Weight_Master 1.1
Recruitment arrangements (for publication) K2_Recruitment material_FLYER_MASTER 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_Spanish 1
Recruitment arrangements (for publication) K2_Recruitment material_LETTER-DR-REFERRAL_MASTER 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Master_CC__WS_Script_Master 2.0
Recruitment arrangements (for publication) K2_Recruitment material_OA_Social_Media_Video_Master 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient_Messaging_Master 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Patient_Messaging_Master_ES TC 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Program_Database_Messaging_Master 3.1
Recruitment arrangements (for publication) K2_Recruitment material_Program_Social_Media_Video_Master 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Program_Website_Copy_Master 3.0
Recruitment arrangements (for publication) K2_Recruitment material_Program_Website_Policies_Master_ES 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Program_Website_Policies_Master_ES TC 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Screener_Ed 2_Master 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Screener_Edition 2_Master_ES TC 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Search_Ads_Master 1.0
Recruitment arrangements (for publication) K2_Recruitment material_TRIAL-BROCHURE_MASTER 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Website_Copy_Master 1.0
Subject information and informed consent form (for publication) K2_Recruitment material_Spanish_ConneX Spain Travel Contact Card 2
Subject information and informed consent form (for publication) K2_Recruitment material_Spanish_ConneX Spain Travel Ref Guide for Subjects 2
Subject information and informed consent form (for publication) K2_Recruitment material_Spanish_Greenphire ClinCard Msg Templates 6
Subject information and informed consent form (for publication) K2_Recruitment material_Spanish_Greenphire EU Generic ClinCard 3
Subject information and informed consent form (for publication) K2_Recruitment material_Spanish_Greenphire_ClinCard_Card_Carrier 3
Subject information and informed consent form (for publication) K2_Recruitment material_Spanish_Greenphire_ClinCard_Cardholder_FAQ_EU 3
Subject information and informed consent form (for publication) K2_Recruitment material_Spanish_Greenphire_Fee_Schedule 1
Subject information and informed consent form (for publication) L1_ICF and SIS_Main ICF_Spanish_Redacted 2.0
Subject information and informed consent form (for publication) L1_ICF and SIS_Main ICF_Spanish_TC 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Greenphire ICF_Spanish 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Greenphire ICF_Spanish_TC 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Summary of changes 1_Redacted 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient information card_Spanish 1
Synopsis of the protocol (for publication) D1_Protocol synopsis ENG 2023-503660-17-00_Redacted b
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2023-503660-17-00_Spanish_Redacted 2.0

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-06-20 Spain Acceptable
2023-09-15
 2023-09-15
2 SUBSTANTIAL MODIFICATION SM-1 2023-10-23 Spain Acceptable 2023-12-19
3 NON SUBSTANTIAL MODIFICATION NSM-1 2024-03-07 Spain Acceptable 2024-03-07
4 SUBSTANTIAL MODIFICATION SM-2 2024-03-28 Spain Acceptable 2024-04-25
5 SUBSTANTIAL MODIFICATION SM-4 2025-03-25 Spain Acceptable
2025-05-12
 2025-05-12

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