Clinical trial • Phase III • Endocrinology

LY3437943 SODIUM for Obesity

Phase III trial of LY3437943 SODIUM for Obesity.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Obesity
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
19-06-2024
First CTIS Authorization Date
20-09-2024

Trial design

Randomised, comparator: tirzepatide (ly3298176) — dose and schedule not specified in available data. test: retatrutide (ly3437943) — dose and schedule not specified in available data.-controlled Phase III trial across 20 sites in Poland, Germany.

Randomised
Yes
Comparator
Comparator: Tirzepatide (LY3298176) — dose and schedule not specified in available data. Test: Retatrutide (LY3437943) — dose and schedule not specified in available data.
Target Sample Size
625

Eligibility

Recruits 625 Vulnerable population selected. Subject information and informed consent form documents are listed for the study (e.g., 'L1_SIS and ICF_Main ICF_PL_Redacted', country-specific ICFs). No explicit wording on assent or minor consent procedures is provided in the available data; the trial population is described as adults..

Vulnerable Population
Vulnerable population selected. Subject information and informed consent form documents are listed for the study (e.g., 'L1_SIS and ICF_Main ICF_PL_Redacted', country-specific ICFs). No explicit wording on assent or minor consent procedures is provided in the available data; the trial population is described as adults.

Inclusion criteria

  • {"criterion_text":"- Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight"}

Exclusion criteria

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

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent Change from Baseline in Body Weight","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
625
Recruitment Window Months
24
Consent Approach
Informed consent is addressed via subject information and informed consent form documents provided per country (e.g., Polish and German ICFs are listed). Consent is obtained from participants (adult population); no information on assent for minors is provided. Specific languages available include at least Polish and German as indicated by country-specific ICF documents.

Methods

  • Recruitment poster (Germany) — document: 'K2_Recruitment materials_Poster_DE_Redacted'
  • Website-based recruitment (Poland) — documents: 'K2_Recruitment material_CWM_Program_Website_PL', 'K2_Recruitment material_CWM_Program_Website_Policies_PL', 'K2_Recruitment material_GZBP_Website_Copy_PL'
  • Database/messaging programs (Poland) — document: 'K2_Recruitment material_CWM_Program_Database_Messaging_PL'
  • Online screener (Poland) — document: 'K2_Recruitment material_CWM_Screener_PL'
  • Patient messaging materials (Poland) — document: 'K2_Recruitment material_GZBP_Patient_Messaging_PL'
  • Third-party recruitment vendors listed with duties for patient screening/recruitment/retention (examples include Greenphire LLC, Clinical Trial Media Inc., Clariness GmbH)

Geography

Total Number Of Sites
20
Total Number Of Participants
225

Poland

Earliest CTIS Part Ii Submission Date
16-08-2024
Latest Decision Or Authorization Date
29-04-2025
Processing Time Days
256
Number Of Sites
11
Number Of Participants
145

Sites

Site Name
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
Contact Person Name
Małgorzata Arciszewska
Contact Person Email
malgorzata@arciszewska.eu
Site Name
ZDROWIE OSTEO-MEDIC s.c.
Contact Person Name
Katarzyna Wasilewska
Contact Person Email
k.wasilewska.osteo@gmail.com
Site Name
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
Contact Person Name
Lucyna Ostrowska
Contact Person Email
lucyna.ostrowska@umb.edu.pl
Site Name
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
Contact Person Name
Henryk Rudzki
Contact Person Email
Henryk58@interia.pl
Site Name
Terpa Sp. z o.o. sp.k.
Contact Person Name
Beata Matyjaszek-Matuszek
Contact Person Email
bmm@2com.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Centrum Badań Klinicznych
Contact Person Name
Adam Krętowski
Contact Person Email
adamkretowski@wp.pl
Site Name
NZOZ Neuro-Kard "Ilkowski i Partnerzy" Spółka Partnerska Lekarzy
Contact Person Name
Marzenna Sekulska
Contact Person Email
monika@mirrorman.pl
Site Name
Centrum Zdrowia Metabolicznego
Contact Person Name
Paweł Bogdański
Contact Person Email
pawelbogdanski73@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Endokrynologii, Diabetologii I Chorób Wewnętrznych
Contact Person Name
Anna Popławska-Kita
Contact Person Email
annapoplawskakita@op.pl
Site Name
Centrum Terapii Współczesnej
Contact Person Name
Małgorzata Józefowska
Contact Person Email
m.jozefowska@ctw.com.pl
Site Name
Ekamed Sp. z o.o.
Contact Person Name
Ewa Skokowska
Contact Person Email
skokowska@onet.pl

Germany

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
445
Number Of Sites
9
Number Of Participants
80

Sites

Site Name
Zentrum fur klinische Forschung - Köln
Contact Person Name
Bastian Kirsch
Site Name
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Contact Person Name
Andreas Staudenmeyer
Site Name
RED Oncology GmbH
Contact Person Name
Thomas Schaum
Contact Person Email
schaum@red-institut.de
Site Name
Diabetes-Zentrum-Wilhelmsburg GbR
Contact Person Name
Peter Witzel
Site Name
Medizentrum Essen Borbeck
Contact Person Name
Axel Schaefer
Contact Person Email
axel.schaefer@mzeb.de
Site Name
Diabeteszentrum Hamburg West
Contact Person Name
Dominik Dahl
Contact Person Email
dr.dahl@dzhw.de
Site Name
InnoDiab Forschung GmbH
Contact Person Name
Thomas Schürholz
Contact Person Email
thomas.schuerholz@innodiab.de
Site Name
Ambenet GmbH Das Ambulante Behandlungsnetz
Contact Person Name
Hanz-Detlev Stahl
Contact Person Email
ds@ambenet.de
Site Name
Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob
Contact Person Name
Stephan Jacob
Contact Person Email
prof.dr.jacob@web.de

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Iqvia Rds Inc.
Name
Icon Clinical Research Limited
Responsibilities
Adjudication

Third parties

  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Screening, Recruitment and or Retention","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Brightech International LLC","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Patient screening and recruitment activities","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"IQVIA Uk Ltd ( IQVIA Connected Devices)","duties_or_roles":"ECG analysis/review","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Patient screening and recruitment activities","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Adjudication","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"R&G US Inc","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Techdata Service Company LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Biotel Research LLC","duties_or_roles":"Medical Imaging","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Retatrutide
Active Substance
LY3437943 SODIUM
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Investigational Product Name
Tirzepatide
Active Substance
TIRZEPATIDE
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION

Related trials

Other published trials that may interest you.