A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain ( TRIUMPH-7 )

2024-517431-43-00 Protocol J1I-MC-GZQD Therapeutic confirmatory (Phase III) Ended

End 6 Oct 2025 · Status Ended · 1 EU/EEA countries · 7 sites · Protocol J1I-MC-GZQD

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 550
Countries 1
Sites 7

Overweight

To demonstrate that retatrutide MTD is superior to placebo for change in average pain intensity and 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] - Musculoskeletal Diseases [C05]
Trial duration
completed 6 Oct 2025
Decision date (initial)
2025-04-06
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-517431-43-00
WHO UTN
U1111-1312-7233

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

To demonstrate that
retatrutide MTD is superior to placebo for change in average
pain intensity and body weight.

Conditions and MedDRA coding

Overweight

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes
EU CT numberTitleSponsor
2023-503659-88-00 J1I-MC-GZBM: A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants with Severe Obesity and Established Cardiovascular Disease (TRIUMPH-3) Eli Lilly & Co.
2023-503658-11-00 J1I-MC-GZBK: A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants with Type 2 Diabetes Mellitus Who Have Obesity or Overweight: A Randomized Double-Blind, Placebo-Controlled Trial (TRIUMPH-2) Eli Lilly & Co.
2023-503660-17-00 J1I-MC-GZBN:A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants who have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial Eli Lilly & Co.
2024-511450-49-00 J1I-MC-GZBP: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity Eli Lilly & Co.
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.
2023-503657-35-00 J1I-MC-GZBJ: A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1); J1I-MC-GOA1: Indication-Specific Appendix (ISA2) for participants with knee osteoarthritis (OA) Eli Lilly & Co.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Have had low back pain for at least the last 6 months
  2. Be overweight
  3. Have tried to lose weight by changing what they eat but it did not work

Exclusion criteria 3

  1. Have a change in body weight greater than 11 pounds.
  2. Have diabetes
  3. Have prior history of low back surgery

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Change from Baseline in Weekly Average Pain Intensity-Numeric Rating Scale (API-NRS) Score [Time Frame: Baseline, up to 72 weeks]
  2. Percent Change from Baseline in Body Weight [Time Frame: Baseline, up to 72 weeks]

Investigational products

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

Test 5

Retatrutide

PRD11780021 · 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

PRD11780017 · 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

PRD11780020 · 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

PRD11780019 · 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

PRD11780018 · 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 to match LY

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 16

OrganisationCity, countryDuties
Labcorp Central Laboratory Services SARL
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Code 5
Florence
ORL-000012320
 Atlanta, United States Data management
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Iqvia Biotech LLC
ORG-100008704
 Durham, United States Laboratory analysis
Bioclinica Inc.
ORG-100033079
 Princeton, United States Laboratory analysis
Iqvia Rds Inc.
ORG-100043858
 Durham, United States On site monitoring, Code 5
The Hibbert Co.
ORG-100047639
 Trenton, United States Code 2
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Code 13
Trialbee AB
ORG-100051369
 Malmo, Sweden Code 2
Cleveland Clinic Foundation
ORG-100028017
 Cleveland, United States Code 13
Q2 Solutions LLC
ORG-100017000
 Ithaca, United States Laboratory analysis
Lionbridge AG
ORL-000012316
 Basel, Switzerland Other
Zoom
ORL-000012319
 San Jose, United States Other
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Laboratory analysis
Medable Inc.
ORG-100043083
 Palo Alto, United States Data management

Locations

1 EU/EEA country · 7 investigational sites

By country

CountryMS statusPlanned subjectsSites
Poland Ended 85 7
Rest of world
United States, Canada, Argentina, Mexico
 — 465 —

Investigational sites

Poland

7 sites · Ended
Diamond Clinic Sp. z o.o.
N/A, Ul. Stefana Rogozinskiego 6/U3, 31-559, Cracow
Santa Sp. z o.o.
N/A, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Revit Sp. z o.o.
N/A, Ul. Swobodna 38, 15-756, Bialystok
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
Terpa Sp. z o.o. sp.k.
N/A, Ul. Pogodna 34, 20-333, Lublin
Centrum Zdrowia Metabolicznego Paweł Bogdański
N/A, ul. 14F Nowina, 60-589, Poznań
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul Wronia 53 Lok B 10, 00-874, Warsaw

Results and documents

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

Documents 24 files

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

TypeTitleVersion
Protocol (for publication) D1_LY3437943 GZQD ERB Supplement_CTIS_Redacted 1
Protocol (for publication) D1_Protocol 2024-517431-43-00_Redacted Initial
Protocol (for publication) D4_Patient facing documents_copyright statement 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_PL 1.0
Recruitment arrangements (for publication) K2_Recruitment arrangments_Informed consent and patient recruitment procedure_PL 1.0
Recruitment arrangements (for publication) K3_Other subject information material_Flyer_PL 1
Recruitment arrangements (for publication) K3_Other subject information material_Poster_PL 1
Recruitment arrangements (for publication) K3_Other subject information material_Trial-Brochure_PL 1
Recruitment arrangements (for publication) K4_Recruitment material_Trialbee_Digital Marketing Content_PL 1
Recruitment arrangements (for publication) K4_Recruitment material_Trialbee_Global Privacy Policy_PL 1
Recruitment arrangements (for publication) K4_Recruitment material_Trialbee_Landing Page_PL 1
Recruitment arrangements (for publication) K4_Recruitment material_Trialbee_OverviewSupplementaryInformation_ENG 1
Recruitment arrangements (for publication) K4_Recruitment material_Trialbee_SecondaryAssessment_PL 1
Recruitment arrangements (for publication) K4_Recruitment material_Trialbee_Self_Assessment_PL 1
Subject information and informed consent form (for publication) L1_SIS and ICF_PL_Main ICF_GZQD_Redacted 5
Subject information and informed consent form (for publication) L2_Other subject information material_Instruction for use_PL 1
Subject information and informed consent form (for publication) L2_Other subject information material_KwikPen Video Screenshots_PL 1
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 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_ZoomHealth_TermsofService 1
Subject information and informed consent form (for publication) L3_Info Re insurance Conditions for Patient_PL 1.0
Subject information and informed consent form (for publication) L4_Patient Documents Not submitted_PL 1.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis 2024-517431-43-00_ENG_Redacted 1.0
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_2024-517431-43-00_Redacted_PL 1.0

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-12-06 Poland Acceptable
2025-03-27
 2025-04-06
2 SUBSTANTIAL MODIFICATION SM-1 2025-04-25 Poland Acceptable
2025-06-08
 2025-06-13
3 SUBSTANTIAL MODIFICATION SM-2 2025-07-17 Poland Acceptable 2025-09-12

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