ObesityPhase 3AMPLIFY-2NCT07881458
A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes
A Phase 3 study testing eloralintide and tirzepatide and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 75 sites in 10 countries.
Trial summary
The purpose of this study is to investigate the efficacy and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared to tirzepatide for body weight reduction in participants with obesity or overweight and type 2 diabetes. 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, Overweight, Diabetes Mellitus, Type 2
- What is being tested?
- eloralintide and tirzepatide and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 75 sitesin 10 countries
- Study dates
- Nov 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 type 2 diabetes
- Have a stable self-reported body weight (<5% body weight change) for 90 days prior to screening
- Have a BMI of ≥27 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
- Have taken any of the following within 90 days prior to screening
- medications with direct amylin, glucagon-like peptide-1 (GLP-1) or glucagon-dependent insulinotropic polypeptide (GIP) receptor activity, including compounded therapies
- dipeptidyl peptidase 4 (DPP-4) inhibitors, and
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- insulin
- Have had within 90 days prior to screening:
- heart attack
- stroke
- 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 medications or alternative remedies intended for weight loss within 90 days of screening
Trial locations and contacts
75 sites in 10 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
75 sites in 10 countries
United States25 sites
Washington Center for Weight Management and Research
Arlington, Virginia, 22206
7038070037
Domenica Rubino
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
303-724-9005
Daniel Bessesen
IMA Clinical Research Austin
Austin, Texas, 78745
5126490082
Nomita Kim
Care Access - Dalton - Clinical Trials Center by Walmart & Care Access
Dalton, Georgia, 30720
877-791-0656
Chukwukanene Ofiaeli
Care Access - Eunice
Eunice, Louisiana, 70535
3374578841
Randall Miller
Diabetes and Thyroid Center of Ft. Worth
Fort Worth, Texas, 76132
8172630007
Anjanette Tan
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817
8085260303
ALAN PARSA
Juno Research
Houston, Texas, 77040
713-779-5494
Damaris Vega
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
Pacific Clinical Studies Inc.
Los Alamitos, California, 90720
562-598-0600 ext 205
Etsegenet Ayele
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015
213-373-8380
Juan Frias
Tandem Clinical Research
Marrero, Louisiana, 70072
504-934-8424
Adil Fatakia
ERA Health Research-Texas
Midland, Texas, 79707
4325287555
Sapna Chilka
Texas Valley Clinical Research (TVCR) - Mission
Mission, Texas, 78572
Alejandro Gonzalez Campos
NYC Research
New York, New York, 10016
516-574-9232
Anastasios Manessis
IMA Clinical Research NYC Midtown
New York, New York, 10036
Eli Shalenberg
American Research Centers of Florida
Pembroke Pines, Florida, 33027
9542373799
Nora Bassam Khoury
Eastside Research Associates
Redmond, Washington, 98052
(425) 869-6828
Christopher Price
IMA Clinical Research San Antonio
San Antonio, Texas, 78229
210-692-7157
Lisa Blair
Care Access - St. Louis
St Louis, Missouri, 63131
Anthony Margherita
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
IMA Clinical Research Warren
Warren Township, New Jersey, 07059
Samar Hameed
Encore Medical Research - Weston
Weston, Florida, 33331
954-777-8827
Sandro Bacchelli
Romania10 sites
CMI Cardiologie - Dr. Mercea Corina Delia
Baia Mare, 430124
0040724044581
Mihaela Mociran
C.M.D.T.A. Neomed
Brasov, 500283
0040762249010
Liliana Marin
Geea Medical Easy Diet
Bucharest, 010627
40314288633
Georgeta Vacaru
Centrul Medical NutriLife
Bucharest, 013764
0040212323445
Marlena Pascu
Futuremeds - București
Bucharest, 031441
+40 723 680 497
Oana-Andreea Parliteanu
Futuremeds - Craiova 2
Craiova, 200528
40763670811
Ionela Mihaela Vladu
Futuremeds - Galați
Galați, 800183
0040724405355
Cristina-Victoria Mistodie
Gama Diamed
Mangalia, 905500
0040241740581
Amalia Thury-Burileanu
Diabdana
Oradea, 410147
004 0722 480 224
Dana Cosma
Clinica Korall
Satu Mare, 440055
40746013882
Adriana Filimon
Spain9 sites
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
655624017
Alfonso Soto Gonzalez
Hospital Universitario de La Ribera
Alzira, 46600
34657845358
carmen fajardo
Hospital Universitari Vall d'Hebron
Barcelona, 08035
34697817352
ANDREEA CIUDIN
Hospital Clínic de Barcelona
Barcelona, 08036
34660560288
Ana de Hollanda
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, 15405
Alma Maria Prieto tenreiro
Hospital Vithas La Salud
Granada, 18008
658011529
Cristobal Morales Portillo
H.R.U Málaga - Hospital Civil
Málaga, 29009
951290305
GABRIEL OLVEIRA
Hospital Universitario Virgen Del Rocio
Seville, 41013
955012000
Virginia Bellido
Vithas Hospital Sevilla
Seville, 41950
658011529
Cristobal Morales Portillo
China7 sites
The Second Hospital of Jilin University
Changchun, 130041
Hanqing Cai
Jinan Central Hospital
Jinan, 250013
Nianrong Mi
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, 471023
13653880139
Hongwei Jiang
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, 210011
18951762960
Yibing Lu
Ningbo First Hospital
Ningbo, 315010
13757426626
Li Li
The First Hospital of Hebei Medical University
Shijiazhuang, 50000
Huijuan Ma
Tianjin Medical University Zhu Xianyi Memorial Hospital
Tianjin, 300400
Liming Chen
Brazil6 sites
Centro de Pesquisa Sao Lucas
Campinas, 13060-803
55 19 3343-8688
Danilo Villagelin Neto
Cline Research Center
Curitiba, 80030-480
+554130273930
Silmara Leite
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, 90430-001
555137796400
Luis Henrique Canani
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, 20241-180
552125277979
Renata Alexandra Pinheiro
CPCLIN
São Paulo, 01228-200
551126303777
Denise Franco
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010
551122713450
Breno Balabem Alves
Germany6 sites
StudyPoint Duisburg
Duisburg, 47269
+491725448897
Matthias Kuenster
Diabetes Zentrum Wilhelmsburg
Hamburg, 21109
0049407541703
Peter Witzel
Institut für Diabetesforschung GmbH Münster
Münster, 48145
0049 251 935 2321
Ludger Rose
Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
Münster, 48153
02517775888
Winfried Keuthage
FutureMeds Offenbach
Offenbach, 63065
0049 69 247433849
Christel Contzen
RED-Institut GmbH
Oldenburg, 23758
0049436150630128
Thomas Schaum
Japan5 sites
Medical Corporation Chiseikai Tokyo Center Clinic
Chūōku, 103-0027
81120023812
Hirotaka Nagashima
Tokyo Asbo Clinic
Chūōku, 104-0031
81120023812
Akiyoshi Uchiyama
Chiba Saiseikai Narashino hospital
Narashino, 275-8580
81120023812
Takuya Minamizuka
Soka Sugiura Internal Medicine Clinic
Sōka, 340-0015
81120023812
Tatsushi Sugiura
Tsuchiura Beryl Clinic
Tsuchiura, 300-0062
81120023812
Kota Yamada
South Korea5 sites
Korea University Ansan Hospital
Ansan-si, 15355
82314124274
NANHEE KIM
Chosun University Hospital
Gwangju, 61453
Sang Yong Kim
Seoul National University Bundang Hospital
Seongnam, 13620
Soo Lim
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
1093908214
kyungwan Min
Severance Hospital, Yonsei University Health System
Seoul, 03722
Byung Wan Lee
Puerto Rico1 site
Latin Clinical Trial Center
San Juan, 00909
7879859911
Alex Gonzalez-Bossolo
About this study
Official title: A Phase 3 Study to Investigate the Efficacy and Safety of LY900043 in Adult Participants With Obesity or Overweight and Type 2 Diabetes
The purpose of this study is to investigate the efficacy and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared to tirzepatide for body weight reduction in participants with obesity or overweight and type 2 diabetes.
Participation in the study will last about 2 years.
- Conditions
- Obesity, Overweight, Diabetes Mellitus, Type 2
- Being tested
- eloralintide and tirzepatide, Tirzepatide
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
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
TirzepatideDrug
Also called LY3298176
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| EloraTZP | Experimental | Participants will receive EloraTZP subcutaneously (SC) Receives: Drug: eloralintide and tirzepatide |
| Tirzepatide | Experimental | Participants will receive tirzepatide SC Receives: Drug: Tirzepatide |
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 (21)
Change from Baseline in Waist Circumference
Measured: Baseline, Week 100
Change from Baseline in Hemoglobin A1c (HbA1c)
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 Fasting Glucose
Measured: Baseline, Week 100
Percentage of Participants who Achieve a Composite of Body Weight Reduction ≥ 15% and HbA1c <6.5%
Measured: Week 100
Percent Change from Baseline in Total Cholesterol
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) Total 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, 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 startNov 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
- 1,000 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
- NCT07881458
- Sponsor's protocol ID
- 27837
- Other IDs
- J7C-MC-YQAB, 2026-527230-31-00
- Acronym
- AMPLIFY-2
- 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.