ObesityPhase 3AMPLIFY-1NCT07881432
A Study of EloraTZP in Adult Participants With Obesity Without Type 2 Diabetes
A Phase 3 study testing eloralintide and tirzepatide, Eloralintide and Tirzepatide in people with Obesity, run by Eli Lilly and Company at 155 sites in 9 countries.
Trial summary
The purpose of this study is to investigate the efficacy and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared with tirzepatide, eloralintide and placebo for body weight reduction in participants with obesity. Participation in the study will last about 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- eloralintide and tirzepatide, Eloralintide and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,115 participants
- Where
- 155 sitesin 9 countries
- Study dates
- Dec 2026to Nov 2029
- Phase
- Phase 3
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 a stable self-reported body weight (<5% body weight change) for 90 days prior to screening
- Have a BMI of ≥35 kg/m2 at screening
- Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight
Who cannot join
- Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)
- Have a prior or planned endoscopic procedure and/or device-based therapy for obesity and/or type 2 diabetes (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Have had within 90 days prior to screening:
- heart attack
- stroke
Show all 12Show fewer
- coronary artery revascularization
- unstable angina, or
- hospitalization due to congestive heart failure
- Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure
- Have taken any glucose-lowering medication within 90 days of screening
- Have taken medications or alternative remedies intended for weight loss within 90 days of screening
Trial locations and contacts
155 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
155 sites in 9 countries
United States55 sites
IMA Clinical Research Albuquerque
Albuquerque, New Mexico, 87109
5058483773
Shenif Ladak
Care Access - Arlington 2
Arlington, Virginia, 22206
877-791-0656
Chih Chao Yang
Washington Center for Weight Management and Research
Arlington, Virginia, 22206
7038070037
Domenica Rubino
JEM Research Institute
Atlantis, Florida, 33462
5619682933
David Halpert
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
410 602-1440
Sarah Herts
Care Access - Baltimore
Baltimore, Maryland, 21213
877-791-0656
Peta-Gay Jackson Booth
JCCT - Juno Bellaire Site
Bellaire, Texas, 77401
713-779-5494
Rocio Harbison
The University of Texas Health Science Center at Houston
Bellaire, Texas, 77401
713-486-1350
Deborah Horn
Brigham and Women's Hospital Diabetes Program
Boston, Massachusetts, 02115
6177324245
Vanita Aroda
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
9849743004
Klara Klein
IMA Clinical Research Chicago
Chicago, Illinois, 60641
Nadijda Bassil
Valley Clinical Trials, Inc.
Covina, California, 91723
310-309-9491
Linda Glaser
Cedar Health Research
Dallas, Texas, 75251
214-253-8170
Sefanit Gebretsadik
Care Access - Dalton Walmart
Dalton, Georgia, 30720
877-791-0656
Chukwukanene Ofiaeli
Teak Research Consults - Dunwoody
Dunwoody, Georgia, 30338
4704034755
Aakar Thaker
Cedar Health Research - Euless
Euless, Texas, 76040
2142538170
Debbie Bridges
Care Access - Eunice
Eunice, Louisiana, 70535
3374578841
Randall Miller
Medication Management
Greensboro, North Carolina, 27401
3367636968
James Franklin
East-West Medical Research Institute
Honolulu, Hawaii, 96814
8085316886
Cindy Pau
Biopharma Informatic, LLC
Houston, Texas, 77043
281-944-3610
Agadadash Kuliev
PlanIt Research, LLC
Houston, Texas, 77079
713-973-3415
Christina Michaelis
Care Access - Houston - Clinical Trials Center by Walmart & Care Access
Houston, Texas, 77082
877-791-0656
Ali Bajwa
DM Clinical Research - Indianapolis
Indianapolis, Indiana, 46254
463-271-3050
Brandon Essink
Activian Clinical Research
Kingwood, Texas, 77339
832 969 3401
Martin Basaldua
IMA Clinical Research Las Vegas
Las Vegas, Nevada, 89102
702-463-8888
Nasim Amjadi
Palm Research Center Sunset
Las Vegas, Nevada, 89148
Ellen Neylon
NYC Research INC
Long Island City, New York, 11106
516-574-9232
Anastasios Manessis
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015
213-373-8380
Juan Frias
K2 Medical Research - Maitland
Maitland, Florida, 32751
407-810-2790
Neel Patel
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119
9018431045
Lisa Usdan
Care Access - 801 South Power Road, Mesa
Mesa, Arizona, 85206
877-791-0656
Michael Waters
Clinical Trials Management, LLC d/b/a Flourish Research
Metairie, Louisiana, 70006
5044551310
David Dulitz
Flourish Research - Miami, LLC
Miami, Florida, 33135
305-631-6704
Mark Rosenthal
Yale University School of Medicine
New Haven, Connecticut, 06519
(203) 785-7421
Ania Jastreboff
Weill Cornell Medical College
New York, New York, 10021
646-962-2424
Alpana Shukla
IMA Clinical Research NYC Midtown
New York, New York, 10036
Eli Shalenberg
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
757-591-8100
George Freeman
Eastern Virginia Medical School (EVMS) Medical Group
Norfolk, Virginia, 23510
757-446-5291
Elias Siraj
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
215-676-6696
JOSEPH HEETHER
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462
Cameron Olezene
Care Access - Raleigh
Raleigh, North Carolina, 27607
877-791-0656
Chandar Abboy
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
601-567-1321
Bob Hutchins
Peninsula Research Associates
Rolling Hills Estates, California, 90274
3102651623
Lawrence Sher
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
210-949-0122
Douglas Denham
Artemis Institute for Clinical Research
San Diego, California, 92123
858-278-3647
Stacey Layle
Southern California Clinical Research
Santa Ana, California, 92701
7144742173
Wayne Ho
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
480-725-8708
Benjamin Clark
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
210-545-4900
Michelle Welch
Clinical Research Atlanta
Stockbridge, Georgia, 30281
770-507-6867
Jason Agran
Care Access - Tamarac
Tamarac, Florida, 33321
877-791-0656
Brad Lipson
Care Access - Tampa
Tampa, Florida, 33625
813-771-5980
Shital Mehta
Tucson Clinical Research Institute
Tucson, Arizona, 85712
Girish Karamchandani
Care Access - Tyler - Clinical Trials Center by Walmart & Care Access
Tyler, Texas, 75704
877-791-0656
Alphonse Ekole
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
470-317-3604
Dwight Blake
Kalo Clinical Research
West Valley City, Utah, 84120
Joshua Alam
China25 sites
Luhe Hospital
Beijing, 100000
Dong Zhao
Peking University First Hospital
Beijing, 100034
Ying Gao
Peking University People's Hospital
Beijing, 100034
13910978815
Linong Ji
The Second Hospital of Jilin University
Changchun, 130041
Hanqing Cai
The Third Xiangya Hospital of Central South University
Changsha, 410013
Ping Jin
Sichuan Provincial People's Hospital
Chengdu, 610072
Limin Tian
2nd Affiliated Hospital Chongqing Medical Universi
Chongqing, 400000
13594028475
Dongfang Liu
Zhujiang Hospital
Guangzhou, 510280
Jia Sun
The First Affiliated Hospital of Jinan University
Guangzhou, 510630
jingge yang
The Second People's Hospital of Hefei
Hefei, 230011
86-13956099720
Jun Ye
Jinan Central Hospital
Jinan, 250013
Nianrong Mi
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, 471000
13653880139
Hongwei Jiang
Affiliated Hospital of Luzhou Medical College
Luzhou, 646000
Qin Wan
Jiangxi Provincial People's Hospital
Nanchang, 330038
13767035719
Zongyou Cheng
Nanjing First Hospital
Nanjing, 210006
Qian Li
Jiangsu Province Official Hospital
Nanjing, 210008
Wei Tang
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
18951762960
Yibing Lu
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, 211100
025-52105625
Kun Wang
The First Affiliated Hospital of Nanyang Medical College
Nanyang, 473007
13837739967
Dexue Liu
Ningbo First Hospital
Ningbo, 315010
13757426626
Li Li
The First Hospital of Qinhuangdao
Qinhuangdao Shi, 066000
15903366689
Bowei Liu
Jiading District Central Hospital
Shanghai, 201800
Lixia Suo
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
Huijuan Ma
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Bimin Shi
Xianyang Hospital of Yan'an University
Xianyang, 712000
18391081568
Fang Wang
Argentina20 sites
Instituto de Investigaciones Clínicas Bahia Blanca
Bahía Blanca, 8000
54 9291 4529990
Daniel Vogel
DOLZ Investigación Clínica
Buenos Aires, 1045
Mariano Dolz
Cicemo Srl
Buenos Aires, 1424
541160410129
Alejandro de Dios
Consultorio Medico Investigador Principal Dr Besada
Buenos Aires, 1426
4896-1734
Diego Besada
Centro Médico Viamonte
Buenos Aires, C1120AAC
54 1149635650
Diego Aizenberg
Mautalen Salud e Investigación
Buenos Aires, C1128AAF
541145143400
Jose Fretes
CEMEDIC
Buenos Aires, C1407GTN
Olga Paez
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC
01148019001
Antonela Mainardi
IDIM - Instituto de Investigaciones Metabólicas
Ciudad de Buenos Aires, C1012AAR
Maria Zanchetta
Centro Medico Privado San Vicente Diabetes
Córdoba, 5006
03514584801
Mariana Peralta
MICA - Medicina e Investigación Cardiometabólica
Del Viso, 1669
54 11 3845-9542
Micaela Mirada
Hospital Español de Mendoza
Godoy Cruz, 5501
+54 9 2614727364
Matias Arrupe
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152
5493412106243
Juan Dominguez
CMD-Centro Médico y Diagnóstico por Imágenes
Junín, 6000
2364683120
Maria Pelagagge
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, 7600
542234917628
Andres Alvarisqueta
Instituto de Cardiología Wolff
Mendoza, 5500
5492615636018
SEBASTIAN WOLFF
Instituto Médico Catamarca IMEC
Rosario, 2000
3416176661
Natacha Maldonado
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, 2000
543416928531
Horacio Sessa
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, T4000AXL
03814200180
Magdalena Martinez Romero
Sanatorio Norte
Santiago del Estero, 4200
0384154125573
Franklin Abalos
South Korea13 sites
Korea University Ansan Hospital
Ansan-si, 15355
82314124274
NANHEE KIM
Pusan National University Yangsan Hospital
Busan, 50612
82-55-360-2860
Sang Yeoup Lee
Hanyang University Guri Hospital
Guri-si, 11923
Sangmo Hong
Chosun University Hospital
Gwangju, 61453
Sang Yong Kim
Yeungnam Univeristy Medical Center
Gyeongsan-si, 42415
82-10-9370-3846
KYUCHANG WON
Kyungpook National University Hospital
Junggu, 41944
Hae-Jin Ko
Gachon University Gil Medical Center
Namdong-gu, 21565
+82-32-458-2778
Kyoung-Kon Kim
Konyang University Hospital
Seogu, 35365
Jee Hyun Kang
Seoul National University Bundang Hospital
Seongnam, 13620
Kiheon Lee
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496
Young-Sang Kim
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
1093908214
kyungwan Min
Seoul National University Hospital
Seoul, 03080
BeLong Cho
Severance Hospital, Yonsei University Health System
Seoul, 03722
Byung Wan Lee
India12 sites
Avron Hospitals
Ahmedabad, 380013
079 66 200480
Tiven Marwah
GMERS Medical College and General Hospital
Baroda, 390021
Varsha Godbole
CentraCare Super Speciality Hospital and Medical Research Centre
Belagavi, 59006
Neeta Deshpande
Rajiv Gandhi Government General Hospital
Chennai, 600003
Dr. Ranjith Pratap Shanmugam
Endolife Speciality Hospitals
Guntur, 522001
9849945577
Kongara Srikanth
Karnataka Institute of Medical Sciences
Hubli, 580021
RAM KAULGUD
Atmaram Child Care
Kanpur, 208011
Manish Singh
Yatharth Super Speciality Hospital - Noida Extension
Noida, 201306
Nishant Singh
Lifepoint Multispeciality Hospital
Pune, 411057
Sachin Shivnitwar
All India Institute of Medical Sciences
Raipur, 492099
Pankaj Kannauje
Pacific Medical College & Hospital
Udaipur, 313001
Nilesh Patira
Christian Medical College Vellore
Vellore, 632004
Nitin Kapoor
Germany11 sites
FutureMeds Berlin
Berlin, 10629
+49 30 439741 239
Peter Hahn
Siteworks GmbH - Bochum
Bochum, 44787
+49 234 60144350
Annemone Koechel
Zentrum fur klinische Forschung - Köln
Cologne, 51069
00492212972813
Bastian Kirsch
InnoDiab Forschung Gmbh
Essen, 45136
Gundega Sipola
Hausarztzentrum Butendorf
Gladbeck, 45968
0049204329460
Zuhal Kundakci
Diabeteszentrum Hamburg West
Hamburg, 22607
4940896295
Dominik Dahl
AmBeNet GmbH
Leipzig, 04107
4934196276326
Hans-Detlev Stahl
UKSH Campus Lübeck, Med. 1 - AG Meyhöfer
Lübeck, 23538
49451 50075673
Svenja Meyhöfer
FutureMeds Offenbach
Offenbach, 63065
0049 69 247433849
Christel Contzen
RED-Institut GmbH
Oldenburg, 23758
0049436150630128
Thomas Schaum
Sanos Clinic
Ratingen, 40882
021025643873
Jens Harmel
Japan10 sites
Yotsuya Medical Cube
Chiyoda City, 102-0084
81120023812
Akio Kanazawa
Nihonbashi Sakura Clinic
Chūōku, 103-0025
81120023812
Kumie Ito
Medical Corporation Chiseikai Tokyo Center Clinic
Chūōku, 103-0027
81120023812
Hirotaka Nagashima
Tokyo Asbo Clinic
Chūōku, 104-0031
81120023812
Akiyoshi Uchiyama
Mizonokuchi Okamoto Clinic
Kawasaki, 213-0001
81120023812
Yoshihisa Okamoto
aSBo Medical Clinic
Kin-cho, Kunigami-gun, 904-1201
81120023812
HIDEKI RYO
Shimamura Memorial Hospital
Nerima-ku, 177-0051
81120023812
Tatsuto Mizuno
MY Medical Clinic - Shinjuku
Shinjuku, 160-0023
81120023812
YOSHIHIKO CHONO
Clinical Research Hospital Tokyo
Shinjuku-ku, 160-0004
81120023812
Hiroyuki Fukase
Urasoe General Hospital
Urasoe, 901-2102
81120023812
Toshiya Chinen
United Kingdom6 sites
Layton Medical Centre
Blackpool, FY3 7EN
441253951943
Rebecca Clark
Ashton Medical Group - Chapel House
Lancashire, OL6 6EW
Omair Razzaq
St Pancras Clinical Research
London, EC2Y 8EA
Sandra Bonsu
Atlantic Medical
Penzance, TR18 3DX
Alex Dewdney
Abbeywell Surgery
Romsey, SO51 7QN
01794 512218
Nicola Lester
Marine Lake Medical Practice
West Kirby, CH48 5AA
James Perry
Puerto Rico3 sites
Puerto Rico Medical Research
Ponce, 00717
787-284-5366
Jose Santiago
CMRC Headlands, LLC
San Juan, 00918
Jorge Bustillo
Miralles Clinical Research
San Juan, 00921
787-226-1014
Eduardo Miralles-Alonso
About this study
Official title: A Phase 3 Study to Investigate the Efficacy and Safety of LY900043 in Adult Participants With Obesity Without Type 2 Diabetes
The purpose of this study is to investigate the efficacy and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared with tirzepatide, eloralintide and placebo for body weight reduction in participants with obesity.
Participation in the study will last about 2 years.
- Conditions
- Obesity
- Being tested
- eloralintide and tirzepatide, Eloralintide, Tirzepatide, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eloralintide and tirzepatideDrug
Also called LY900043
Administered SC
EloralintideDrug
Also called LY3841136
Administered SC
TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| EloraTZP Dose 1 | Experimental | Participants will receive EloraTZP subcutaneously (SC) Receives: Drug: eloralintide and tirzepatide |
| EloraTZP Dose 2 | Experimental | Participants will receive EloraTZP SC Receives: Drug: eloralintide and tirzepatide |
| EloraTZP Dose 3 | Experimental | Participants will receive EloraTZP SC Receives: Drug: eloralintide and tirzepatide |
| EloraTZP Dose 4 | Experimental | Participants will receive EloraTZP SC Receives: Drug: eloralintide and tirzepatide |
| EloraTZP Dose 5 | Experimental | Participants will receive EloraTZP SC Receives: Drug: eloralintide and tirzepatide |
| Tirzepatide | Experimental | Participants will receive tirzepatide SC Receives: Drug: Tirzepatide |
| Eloralintide | Experimental | Participants will receive eloralintide SC Receives: Drug: Eloralintide |
| Placebo | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 100
Secondary outcomes (20)
Change from Baseline in Waist Circumference
Measured: Baseline, Week 100
Percent Change from Baseline in Triglycerides
Measured: Baseline, Week 100
Change from Baseline in Systolic Blood Pressure
Measured: Baseline, Week 100
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Measured: Baseline, Week 100
Percent Change from Baseline in Total Body Fat Mass
Measured: Baseline, Week 100
Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 100
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 100
Percent Change from Baseline in Fasting Insulin
Measured: Baseline, Week 100
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline, Week 100
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) Score
Measured: Baseline, Week 100
Change from Baseline in EQ-5D-5L Score
Measured: Baseline, Week 100
Change from Baseline in Eating Behaviors and Attitudes Questionnaire (EBAQ) Score
Measured: Baseline, Week 100
Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight
Measured: Baseline, Week 100
Percentage of Participants with a Change in Medication Use
Measured: Baseline through Week 100
Percentage of Participants who Develop Type 2 Diabetes
Measured: Baseline through Week 100
Overall Functional Assessment of Chronic Illness Therapy, Item GP5 (FACT-GP5) Score
Measured: Week 100
Pharmacokinetics (PK): Maximum Concentration of Eloralintide at Steady State (Cmax,ss)
Measured: Baseline through Week 100
PK: Area Under the Concentration Versus Time Curve of Eloralintide for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)
Measured: Baseline through Week 100
PK: Maximum Concentration of Tirzepatide at Steady State (Cmax,ss)
Measured: Baseline through Week 100
PK: Area Under the Concentration Versus Time Curve of Tirzepatide for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)
Measured: Baseline through Week 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 2,115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881432
- Sponsor's protocol ID
- 27836
- Other IDs
- 2026-526047-34-00, J7C-MC-YQAA
- Acronym
- AMPLIFY-1
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 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.