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ObesityPhase 3TRIUMPH-1NCT05929066

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

A Phase 3 study testing Retatrutide in people with Obesity and Overweight, run by Eli Lilly and Company at 134 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight, Osteoarthritis, Knee
What is being tested?
Retatrutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,335 participants
Where
134 sitesin 12 countries
Study dates
10 Jul 2023to 30 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:
  • hypertension
  • dyslipidemia
  • obstructive sleep apnea, or
  • cardiovascular disease
  • History of at least one unsuccessful dietary effort to reduce body weight
Show all 17Show fewer
  • GOA1 Inclusion Criteria:
  • Have index knee pain for >12 weeks prior to screening, and presence of index knee pain for >15 days over the previous month
  • Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening
  • Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.
  • GSA1 Inclusion Criteria:
  • Previously diagnosed with OSA
  • Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
  • For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
  • If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.
  • GZBJ Addenda (2) inclusion criteria:
  • Have completed the final treatment visit of GZBJ Week 80.

Who cannot join

  • Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days.
  • Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
  • Have a prior or planned surgical treatment for obesity.
  • Have diabetes mellitus.
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Have had pancreatitis.
Show all 17Show fewer
  • GOA1 exclusion criteria
  • Have had steroid joint injections within 90 days of screening.
  • Have had other joint injections and procedures within 6 months of screening.
  • Have joint disease other than osteoarthritis.
  • GSA1 exclusion criteria
  • Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
  • Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
  • Use a dental appliance or other device to treat OSA other than PAP therapy.
  • GZBJ Addenda (2) exclusion criteria
  • Have had study intervention discontinuation.
  • Have had permanent dose reduction.

Trial locations and contacts

134 sites in 12 countries.

134 sites in 12 countries

United States39 sites

  • NeuroTrials Research Inc

    Atlanta, Georgia, 30328

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Teradan Clinical Trials, LLC

    Brandon, Florida, 33511

  • Northwestern University

    Chicago, Illinois, 60611

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Valley Research

    Fresno, California, 93720

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Juno Research

    Houston, Texas, 77040

  • Brengle Family Medicine

    Indianapolis, Indiana, 46260

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128

  • Medical Investigations

    Little Rock, Arkansas, 72211

  • Suncoast Research Group

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33165

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee, 37204

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801

  • Central Phoenix Medical Clinic

    Phoenix, Arizona, 85020

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Tribe Clinical Research - Spartanburg

    Spartanburg, South Carolina, 29301

  • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

    Springfield, Illinois, 62711

  • Clinvest Research LLC

    Springfield, Missouri, 65807

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Trial Management Associates - Wilmington - Floral Parkway

    Wilmington, North Carolina, 28403

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

Mexico15 sites

  • Centro de Atención e Investigación Clínica

    Aguascalientes, Aguascalientes, 20119

  • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

    Chihuahua City, Chihuahua, 31110

  • Instituto de Diabetes, Obesidad y Nutricion

    Cuernavaca, Morelos, 62250

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, Jalisco, 44130

  • Clinica de Investigacion en Reumatologia y Obesidad S. C.

    Guadalajara, Jalisco, 44650

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, Jalisco, 44670

  • Unidad de Investigación Clínica y Atención Médica HEPA

    Guadalajara, Jalisco, 44670

  • EME RED Hospitalaria

    Mérida, Yucatán, 97000

  • Kohler and Milstein Research S.A. de C.V.

    Mérida, Yucatán, 97070

  • Centro de Investigacion en Artritis y Osteoporosis SC

    Mexicali, Estado de Baja California, 21200

  • RM Pharma Specialists

    Mexico City, Mexico City, 03100

  • Clinica Omega

    Mexico City, Mexico City, 06700

  • Unidad biomedica avanzada monterrey

    Monterrey, Nuevo León, 64460

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 66460

  • Arké SMO S.A de C.V

    Veracruz, Veracruz, 91910

Other trials in Mexico

India14 sites

  • Avron Hospitals

    Ahmedabad, Gujarat, 380013

  • All India Institute of Medical Sciences

    Bhubaneswar, Odisha, 751019

  • Endolife Speciality Hospitals

    Guntur, Andhra Pradesh, 522001

  • Karnataka Institute of Medical Sciences

    Hubli, Karnataka, 580021

  • Eternal Heart Care Center and Research Institute

    Jaipur, Rajasthan, 302020

  • ILS Hospitals

    Kolkata, West Benga, 700064

  • Wockhardt Hospital - Mumbai Central

    Mumbai, Maharashtra, 400011

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

  • Chellaram Diabetes Institute

    Pune, Maharashtra, 411021

  • Lifepoint Multispeciality Hospital

    Pune, Maharashtra, 411057

  • Surat Institute of Digestive Sciences Hospitals

    Surat, Gujarat, 395002

  • Indian Institute of Diabetes

    Thiruvananthapuram, Kerala, 695031

  • Jothydev's Diabetes and Research Center

    Trivandrum, Kerala, 695032

  • Christian Medical College Vellore

    Vellore, Tamil Nadu, 632004

Other trials in India

Poland12 sites

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

  • INTERCOR

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605

  • Ambulatorium Sp. z o.o.

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Centrum Kliniczno-Badawcze

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk, Pomeranian Voivodeship, 80-546

  • NZOZ Salvia CM

    Katowice, Silesian Voivodeship, 40-772

  • Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci

    Kielce, Świętokrzyskie Voivodeship, 25-355

  • CenterMed Lublin NZOZ

    Lublin, Lublin Voivodeship, 20-044

  • Gabinety TERPA

    Lublin, Lublin Voivodeship, 20-333

  • Centrum Zdrowia Metabolicznego Pawel Bogdanski

    Poznan, Greater Poland Voivodeship, 60-589

  • Private Practice - Dr. Robert Witek

    Tarnów, Lesser Poland Voivodeship, 33-100

  • MICS Centrum Medyczne Warszawa

    Warsaw, Masovian Voivodeship, 00-874

Other trials in Poland

Romania10 sites

  • SC Minimed SRL

    Bacau, Bacău, 600274

  • C.M.D.T.A. Neomed

    Brasov, Brașov County, 500283

  • Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului

    Bucharest, Bucharest, 011053

  • Diamed Obesity

    Galati, Galați County, 800291

  • Centrul Medical Consultmed

    Iași, Iaşi, 700547

  • Gama Diamed

    Mangalia, Constanța County, 905500

  • Diabdana

    Oradea, Bihor County, 410147

  • Clinica Korall

    Satu Mare, Satu Mare County, 440055

  • Policlinica Astra Sibiu

    Sibiu, Sibiu County, 550371

  • Cabinet Medical Dr.Geru

    Timișoara, Timiș County, 300288

Other trials in Romania

Canada9 sites

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1

  • Dr. Steven V. Zizzo Medicine Professional Corporation

    Hamilton, Ontario, L8J 0B6

  • Wharton Medical Clinic

    Hamilton, Ontario, L8L 5G8

  • Centre de Recherche Clinique de Laval

    Laval, Quebec, H7T 2P5

  • Clinique de médecine Urbaine du Quartier Latin

    Montreal, Quebec, H2L 4E9

  • Your Research Network

    Niagara Falls, Ontario, L2H 1H5

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

  • Canadian Phase Onward

    Toronto, Ontario, M3J 0K2

  • C.I.C. Mauricie inc.

    Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

United Kingdom9 sites

  • Heartlands Hospital

    Birmingham, Birmingham, B9 5SS

  • Layton Medical Centre

    Blackpool, Lancashire, FY3 7EN

  • Rowden Surgery

    Chippenham, England, SN15 2SB

  • Panthera Biopartners - North London

    Enfield, London, City of, EN3 4GS

  • Glasgow Royal Infirmary

    Glasgow, Scotland, G31 2ER

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW

  • Aintree University Hospital NHS Foundation Trust

    Liverpool, United Kingdom, L9 7AL

  • St Clare Medical Centre

    Penzance, TR18 3DX

  • Panthera Biopartners - Sheffield

    Sheffield, Sheffield, S2 5FX

Other trials in United Kingdom

Australia8 sites

  • Fusion Clinical Research

    Adelaide, South Australia, 5000

  • Nightingale Research

    Adelaide, South Aust, 5000

  • Emeritus Research

    Botany, New South Wales, 2019

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Barwon Health

    Geelong, Victoria, 3220

  • Logan Hospital

    Meadowbrook, Queensland, 4131

  • The AIM Centre / Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • One Clinical Research

    Nedlands, Western Australia, 6009

Other trials in Australia

Hungary8 sites

  • DRC Gyógyszervizsgáló Központ

    Balatonfüred, Veszprém megye, 8230

  • Óbudai Egészségügyi Centrum

    Budapest, Budapest, 1036

  • ClinDiab Kft.

    Budapest, Budapest, 1089

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Debrecen, 4031

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Debrecen, 4032

  • Medifarma 98 Kft

    Nyíregyháza, Nyíregyháza, 4400

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád megye, 6725

  • Regia Med Kft

    Székesfehérvár, Fejér, 8000

Other trials in Hungary

Spain6 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [La Coruña], 15006

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

    Ferrol, A Coruña [La Coruña], 15405

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Seville, Sevilla, 41003

  • Hospital General Universitario de Valencia

    Valencia, Valenciana, Comunitat, 46014

Other trials in Spain

Brazil3 sites

  • CPQuali Pesquisa Clínica

    São Paulo, São Paulo, 01228-000

  • CPCLIN

    São Paulo, São Paulo, 01228-200

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

Puerto Rico1 site

  • Ponce Medical School Foundation Inc.

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: 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)

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

Being tested
Retatrutide, Placebo
Medical subject headings
Obesity, Overweight, Osteoarthritis, Knee, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetatrutideDrug

    Also called LY3437943

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT05929066
Study groupRoleWhat they receive
Retatrutide Dose 1ExperimentalParticipants will receive retatrutide subcutaneously (SC).
Receives: Drug: Retatrutide
Retatrutide Dose 2ExperimentalParticipants will receive retatrutide SC.
Receives: Drug: Retatrutide
Retatrutide Dose 3ExperimentalParticipants will receive retatrutide SC.
Receives: Drug: Retatrutide
PlaceboPlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo
Retatrutide Extension PeriodExperimentalParticipants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.
Receives: Drug: Retatrutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Body Weight

    Measured: Baseline, Week 80

  2. Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset

    Measured: Baseline, Week 80

  3. Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset

    Measured: Baseline, Week 80

  4. Percent Change from Baseline in Body Weight in Participants in Extension Subset

    Measured: Baseline, Week 104

Secondary outcomes (49)

  1. Percent Change from Baseline in Body Weight in Participants with Baseline BMI ≥ 35 kg/m2

    Measured: Baseline, Week 80

  2. Percentage of Participants who Achieve Body Weight Reduction of ≥ 5%

    Measured: Baseline through Week 80

  3. Percentage of Participants who Achieve Body Weight Reduction of ≥ 10%

    Measured: Baseline through Week 80

  4. Percentage of Participants who Achieve Body Weight Reduction of ≥ 15%

    Measured: Baseline through Week 80

  5. Percentage of Participants who Achieve Body Weight Reduction of ≥ 20%

    Measured: Baseline through Week 80

  6. Percentage of Participants who Achieve Body Weight Reduction of ≥ 25%

    Measured: Baseline through Week 80

  7. Percentage of Participants who Achieve Body Weight Reduction of ≥ 30%

    Measured: Baseline through Week 80

  8. Percentage of Participants who Achieve Body Weight Reduction of ≥ 35%

    Measured: Baseline through Week 80

  9. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 80

  10. Change from Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 80

  11. Percent Change from Baseline in Triglycerides

    Measured: Baseline, Week 80

  12. Percent Change from Baseline in Non-High-Density Lipoprotein (HDL)-Cholesterol

    Measured: Baseline, Week 80

  13. Percent Change form Baseline in Fasting Insulin

    Measured: Baseline, Week 80

  14. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Measured: Baseline, Week 80

  15. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score

    Measured: Baseline, Week 80

  16. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite-CT) Physical Function Composite Score

    Measured: Baseline, Week 80

  17. Change from Baseline in IWQOL-Lite-CT Psychosocial Composite Score

    Measured: Baseline, Week 80

  18. Change from Baseline in Body Mass Index (BMI)

    Measured: Baseline, Week 80

  19. Percentage of Participants who Achieve Waist-to-Height Ratio (WHtR) <0.5

    Measured: Baseline through Week 80

  20. Change from Baseline in HbA1c

    Measured: Baseline, Week 80

  21. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Measured: Baseline, Week 80

  22. Percentage of Participants with a Change in Medication Use

    Measured: Baseline through Week 80

  23. Percentage of Participants who Develop Type 2 Diabetes

    Measured: Baseline through Week 80

  24. Time to Onset of Type 2 Diabetes

    Measured: Baseline through Week 80

  25. Percent Change from Baseline in AHI for GSA1 Subset

    Measured: Baseline, Week 80

  26. Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA1 Subset

    Measured: Baseline to Week 80

  27. Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA1 Subset

    Measured: Week 80

  28. Percent Change from Baseline in Sleep Apnea-Specific Hypoxic Burden for GSA1 Subset

    Measured: Baseline, Week 80

  29. Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-related Impairment 8a T-score for GSA1 Subset

    Measured: Baseline, Week 80

  30. Change from Baseline in AHI Events Per Hour for GSA1 Subset in Participants with Baseline Body Mass Index (BMI) ≥ 35 kg/m2

    Measured: Baseline, Week 80

  31. Percentage of Participants who Achieve AHI < 5 for GSA1 Subset

    Measured: Baseline, Week 80

  32. Change from Baseline in ESS Score for GSA1 Subset

    Measured: Baseline, Week 80

  33. Change from Baseline in Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score

    Measured: Baseline to Week 80

  34. Change from Baseline in PROMIS Sleep Disturbance Short Form 8b T-Score for GSA1 Subset

    Measured: Baseline, Week 80

  35. Change from Baseline in Neck Circumference for GSA1 Subset

    Measured: Baseline, Week 80

  36. Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset

    Measured: Baseline, Week 80

  37. Percentage of Participants who Achieve ≥ 50% Reduction in the WOMAC Pain Subscale for GOA1 Subset

    Measured: Baseline through Week 80

  38. Percentage of Participants who Achieve ≥ 50% Reduction in the WOMAC Physical Function Subscale for GOA1 Subset

    Measured: Baseline through Week 80

  39. Change from Baseline in the WOMAC Pain Subscale Score for GOA1 Subset with Baseline BMI ≥ 35 kg/m2

    Measured: Baseline, Week 80

  40. Change from Baseline in the WOMAC Stiffness Subscale Score for GOA1 Subset

    Measured: Baseline, Week 80

  41. Change from Baseline in the WOMAC Total Score for GOA1 Subset

    Measured: Baseline, Week 80

  42. Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset

    Measured: Baseline, Week 80

  43. Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset

    Measured: Baseline, Week 80

  44. Percentage of Participants with an Improved Categorical Shift in Patient Global Impression of Severity (PGIS) - Target Knee Function for GOA1 Subset

    Measured: Baseline through Week 80

  45. Percentage of Participants with an Improved Categorical Shift in PGIS - Target Knee Pain for GOA1 Subset

    Measured: Baseline through Week 80

  46. Change from Baseline in EQ-5D-5L for GOA1 Subset

    Measured: Baseline, Week 80

  47. Percentage of Participants with a Change in Use of Allowed Concomitant Pain Medication for GOA1 Subset

    Measured: Baseline through Week 80

  48. Change from Baseline in Joint Space Width for GOA1 Subset

    Measured: Baseline, Week 80

  49. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)

    AUC is presented as a single average measure of AUC across the study duration.

    Measured: Baseline through Week 80

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start10 Jul 2023
  3. Primary completion6 Apr 2026
  4. Study completion30 Apr 2026

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05929066
Sponsor's protocol ID
18557
Other IDs
J1I-MC-GZBJ, J1I-MC-GOA1, J1I-MC-GSA1, 2023-503657-35-00, 2023
Acronym
TRIUMPH-1
Status last verified
Aug 2026
First submitted
26 Jun 2023
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
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.

Publications

  • Grunstein RR, Somers VK, Azarbarzin A, Malhotra A, Sands SA, Lucey BP, Allen SE, Giblin K, Falcon BL, Park SY, Lou J, Krueger K; TRIUMPH-1-OSA and TRIUMPH-2-OSA Investigators. Retatrutide Once Weekly for Treatment of Obstructive Sleep Apnea. N Engl J Med. 2026 Oct 21. doi: 10.1056/NEJMoa2611477. Online ahead of print.

    PubMed 42904878

  • Jastreboff AM, Kaplan LM, Davies MJ, Wilding JPH, Ahmad NN, Murray M, Du Y, Makarova N, Giblin K, Schloot NC, Wang Y; TRIUMPH-1 Investigators. Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity. N Engl J Med. 2026 Sep 29. doi: 10.1056/NEJMoa2604169. Online ahead of print.

    PubMed 42814954

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retatrutide in people with Obesity and Overweight, run by Eli Lilly and Company at 134 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Mexico, India, Poland, Romania and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight (time frame: Baseline, Week 80). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05929066, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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