ClinicalTrials.gg
Not yet recruitingNCT07881458AMPLIFY-2Updated Oct 19, 2026

A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes

A Phase 3 interventional study of eloralintide and tirzepatide and Tirzepatide in Obesity, Overweight and Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Not yet recruiting at 75 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight
  • Diabetes Mellitus, Type 2
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
    • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    EloraTZP

    Participants will receive EloraTZP subcutaneously (SC)

    Drug: eloralintide and tirzepatide

  • Experimental
    Tirzepatide

    Participants will receive tirzepatide SC

    Drug: Tirzepatide

Interventions

06

What researchers measure

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 100

Secondary outcomes

  1. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 100

  2. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 100

  3. Change from Baseline in Systolic Blood Pressure

    Time frame: Baseline, Week 100

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

    Time frame: Baseline, Week 100

  5. Percent Change from Baseline in Total Body Fat Mass

    Time frame: Baseline, Week 100

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

    Time frame: Baseline, Week 100

  7. Change from Baseline in Fasting Glucose

    Time frame: Baseline, Week 100

  8. Percentage of Participants who Achieve a Composite of Body Weight Reduction ≥ 15% and HbA1c <6.5%

    Time frame: Week 100

  9. Percent Change from Baseline in Total Cholesterol

    Time frame: Baseline, Week 100

  10. Percent Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 100

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

    Time frame: Baseline, Week 100

  12. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) Total Score

    Time frame: Baseline, Week 100

  13. Change from Baseline in EQ-5D-5L Score

    Time frame: Baseline, Week 100

  14. Change from Baseline in Eating Behaviors and Attitudes Questionnaire (EBAQ) Score

    Time frame: Baseline, Week 100

  15. Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight

    Time frame: Baseline, Week 100

  16. Percentage of Participants with a Change in Medication Use

    Time frame: Baseline, Week 100

  17. Overall Functional Assessment of Chronic Illness Therapy, Item GP5 (FACT-GP5) Score

    Time frame: Week 100

  18. Pharmacokinetics (PK): Maximum Concentration of Eloralintide at Steady State (Cmax,ss)

    Time frame: Baseline through Week 100

  19. PK: Area Under the Concentration Versus Time Curve of Eloralintide for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)

    Time frame: Baseline through Week 100

  20. PK: Maximum Concentration of Tirzepatide at Steady State (Cmax,ss)

    Time frame: Baseline through Week 100

  21. PK: Area Under the Concentration Versus Time Curve of Tirzepatide for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)

    Time frame: Baseline through Week 100

07

Study locations

75 sites
  • Tucson Clinical Research Institute
    Tucson, Arizona 85712, United States
    • Girish Karamchandani · Principal investigator
  • Pacific Clinical Studies Inc.
    Los Alamitos, California 90720, United States
    • · Contact · 562-598-0600 ext 205
    • Etsegenet Ayele · Principal investigator
  • Los Angeles Institute for Metabolic Research
    Los Angeles, California 90015, United States
    • · Contact · 213-373-8380
    • Juan Frias · Principal investigator
  • University of Colorado Anschutz Medical Campus
    Aurora, Colorado 80045, United States
    • · Contact · 303-724-9005
    • Daniel Bessesen · Principal investigator
  • American Research Centers of Florida
    Pembroke Pines, Florida 33027, United States
    • · Contact · 9542373799
    • Nora Bassam Khoury · Principal investigator
  • Encore Medical Research - Weston
    Weston, Florida 33331, United States
    • · Contact · 954-777-8827
    • Sandro Bacchelli · Principal investigator
  • Care Access - Dalton - Clinical Trials Center by Walmart & Care Access
    Dalton, Georgia 30720, United States
    • · Contact · 877-791-0656
    • Chukwukanene Ofiaeli · Principal investigator
  • Pacific Diabetes & Endocrine Center
    Honolulu, Hawaii 96817, United States
    • · Contact · 8085260303
    • ALAN PARSA · Principal investigator
  • DM Clinical Research - Indianapolis
    Indianapolis, Indiana 46254, United States
    • · Contact · 463-271-3050
    • Brandon Essink · Principal investigator
  • Care Access - Eunice
    Eunice, Louisiana 70535, United States
    • · Contact · 3374578841
    • Randall Miller · Principal investigator
  • Tandem Clinical Research
    Marrero, Louisiana 70072, United States
    • · Contact · 504-934-8424
    • Adil Fatakia · Principal investigator
  • Care Access - St. Louis
    St Louis, Missouri 63131, United States
    • Anthony Margherita · Principal investigator
  • IMA Clinical Research Warren
    Warren Township, New Jersey 07059, United States
    • Samar Hameed · Principal investigator
  • NYC Research
    New York, New York 10016, United States
    • · Contact · 516-574-9232
    • Anastasios Manessis · Principal investigator
  • IMA Clinical Research NYC Midtown
    New York, New York 10036, United States
    • Eli Shalenberg · Principal investigator
  • IMA Clinical Research Austin
    Austin, Texas 78745, United States
    • · Contact · 5126490082
    • Nomita Kim · Principal investigator
  • Diabetes and Thyroid Center of Ft. Worth
    Fort Worth, Texas 76132, United States
    • · Contact · 8172630007
    • Anjanette Tan · Principal investigator
  • Juno Research
    Houston, Texas 77040, United States
    • · Contact · 713-779-5494
    • Damaris Vega · Principal investigator
  • Care Access - Houston - Clinical Trials Center by Walmart & Care Access
    Houston, Texas 77082, United States
    • · Contact · 877-791-0656
    • Ali Bajwa · Principal investigator
  • ERA Health Research-Texas
    Midland, Texas 79707, United States
    • · Contact · 4325287555
    • Sapna Chilka · Principal investigator
  • Texas Valley Clinical Research (TVCR) - Mission
    Mission, Texas 78572, United States
    • Alejandro Gonzalez Campos · Principal investigator
  • IMA Clinical Research San Antonio
    San Antonio, Texas 78229, United States
    • · Contact · 210-692-7157
    • Lisa Blair · Principal investigator
  • Care Access - Tyler - Clinical Trials Center by Walmart & Care Access
    Tyler, Texas 75704, United States
    • · Contact · 877-791-0656
    • Alphonse Ekole · Principal investigator
  • Washington Center for Weight Management and Research
    Arlington, Virginia 22206, United States
    • · Contact · 7038070037
    • Domenica Rubino · Principal investigator
  • Eastside Research Associates
    Redmond, Washington 98052, United States
    • · Contact · (425) 869-6828
    • Christopher Price · Principal investigator
  • Centro de Pesquisa Sao Lucas
    Campinas, 13060-803, Brazil
    • · Contact · 55 19 3343-8688
    • Danilo Villagelin Neto · Principal investigator
  • Cline Research Center
    Curitiba, 80030-480, Brazil
    • · Contact · +554130273930
    • Silmara Leite · Principal investigator
  • Núcleo de Pesquisa Clínica do Rio Grande do Sul
    Porto Alegre, 90430-001, Brazil
    • · Contact · 555137796400
    • Luis Henrique Canani · Principal investigator
  • IBPClin - Instituto Brasil de Pesquisa Clínica
    Rio de Janeiro, 20241-180, Brazil
    • · Contact · 552125277979
    • Renata Alexandra Pinheiro · Principal investigator
  • CPCLIN
    São Paulo, 01228-200, Brazil
    • · Contact · 551126303777
    • Denise Franco · Principal investigator
  • CEPIC - Centro Paulista de Investigação Clínica
    São Paulo, 04266-010, Brazil
    • · Contact · 551122713450
    • Breno Balabem Alves · Principal investigator
  • The Second Hospital of Jilin University
    Changchun, 130041, China
    • Hanqing Cai · Principal investigator
  • Jinan Central Hospital
    Jinan, 250013, China
    • Nianrong Mi · Principal investigator
  • The First Affiliated Hospital of Henan University of Science &Technology
    Luoyang Shi, 471023, China
    • · Contact · 13653880139
    • Hongwei Jiang · Principal investigator
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, 210011, China
    • · Contact · 18951762960
    • Yibing Lu · Principal investigator
  • Ningbo First Hospital
    Ningbo, 315010, China
    • · Contact · 13757426626
    • Li Li · Principal investigator
  • The First Hospital of Hebei Medical University
    Shijiazhuang, 50000, China
    • Huijuan Ma · Principal investigator
  • Tianjin Medical University Zhu Xianyi Memorial Hospital
    Tianjin, 300400, China
    • Liming Chen · Principal investigator
  • StudyPoint Duisburg
    Duisburg, 47269, Germany
    • · Contact · +491725448897
    • Matthias Kuenster · Principal investigator
  • Diabetes Zentrum Wilhelmsburg
    Hamburg, 21109, Germany
    • · Contact · 0049407541703
    • Peter Witzel · Principal investigator
  • Institut für Diabetesforschung GmbH Münster
    Münster, 48145, Germany
    • · Contact · 0049 251 935 2321
    • Ludger Rose · Principal investigator
  • Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
    Münster, 48153, Germany
    • · Contact · 02517775888
    • Winfried Keuthage · Principal investigator
  • FutureMeds Offenbach
    Offenbach, 63065, Germany
    • · Contact · 0049 69 247433849
    • Christel Contzen · Principal investigator
  • RED-Institut GmbH
    Oldenburg, 23758, Germany
    • · Contact · 0049436150630128
    • Thomas Schaum · Principal investigator
  • Medical Corporation Chiseikai Tokyo Center Clinic
    Chūōku, 103-0027, Japan
    • · Contact · 81120023812
    • Hirotaka Nagashima · Principal investigator
  • Tokyo Asbo Clinic
    Chūōku, 104-0031, Japan
    • · Contact · 81120023812
    • Akiyoshi Uchiyama · Principal investigator
  • Chiba Saiseikai Narashino hospital
    Narashino, 275-8580, Japan
    • · Contact · 81120023812
    • Takuya Minamizuka · Principal investigator
  • Soka Sugiura Internal Medicine Clinic
    Sōka, 340-0015, Japan
    • · Contact · 81120023812
    • Tatsushi Sugiura · Principal investigator
  • Tsuchiura Beryl Clinic
    Tsuchiura, 300-0062, Japan
    • · Contact · 81120023812
    • Kota Yamada · Principal investigator
  • Latin Clinical Trial Center
    San Juan, 00909, Puerto Rico
    • · Contact · 7879859911
    • Alex Gonzalez-Bossolo · Principal investigator
  • CMI Cardiologie - Dr. Mercea Corina Delia
    Baia Mare, 430124, Romania
    • · Contact · 0040724044581
    • Mihaela Mociran · Principal investigator
  • C.M.D.T.A. Neomed
    Brasov, 500283, Romania
    • · Contact · 0040762249010
    • Liliana Marin · Principal investigator
  • Geea Medical Easy Diet
    Bucharest, 010627, Romania
    • · Contact · 40314288633
    • Georgeta Vacaru · Principal investigator
  • Centrul Medical NutriLife
    Bucharest, 013764, Romania
    • · Contact · 0040212323445
    • Marlena Pascu · Principal investigator
  • Futuremeds - București
    Bucharest, 031441, Romania
    • · Contact · +40 723 680 497
    • Oana-Andreea Parliteanu · Principal investigator
  • Futuremeds - Craiova 2
    Craiova, 200528, Romania
    • · Contact · 40763670811
    • Ionela Mihaela Vladu · Principal investigator
  • Futuremeds - Galați
    Galați, 800183, Romania
    • · Contact · 0040724405355
    • Cristina-Victoria Mistodie · Principal investigator
  • Gama Diamed
    Mangalia, 905500, Romania
    • · Contact · 0040241740581
    • Amalia Thury-Burileanu · Principal investigator
  • Diabdana
    Oradea, 410147, Romania
    • · Contact · 004 0722 480 224
    • Dana Cosma · Principal investigator
  • Clinica Korall
    Satu Mare, 440055, Romania
    • · Contact · 40746013882
    • Adriana Filimon · Principal investigator
  • Korea University Ansan Hospital
    Ansan-si, 15355, South Korea
    • · Contact · 82314124274
    • NANHEE KIM · Principal investigator
  • Chosun University Hospital
    Gwangju, 61453, South Korea
    • Sang Yong Kim · Principal investigator
  • Seoul National University Bundang Hospital
    Seongnam, 13620, South Korea
    • Soo Lim · Principal investigator
  • Nowon Eulji Medical Center, Eulji University
    Seoul, 01830, South Korea
    • · Contact · 1093908214
    • kyungwan Min · Principal investigator
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, South Korea
    • Byung Wan Lee · Principal investigator
  • CHUAC-Complejo Hospitalario Universitario A Coruña
    A Coruña, 15006, Spain
    • · Contact · 655624017
    • Alfonso Soto Gonzalez · Principal investigator
  • Hospital Universitario de La Ribera
    Alzira, 46600, Spain
    • · Contact · 34657845358
    • carmen fajardo · Principal investigator
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
    • · Contact · 34697817352
    • ANDREEA CIUDIN · Principal investigator
  • Hospital Clínic de Barcelona
    Barcelona, 08036, Spain
    • · Contact · 34660560288
    • Ana de Hollanda · Principal investigator
  • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
    Ferrol, 15405, Spain
    • Alma Maria Prieto tenreiro · Principal investigator
  • Hospital Vithas La Salud
    Granada, 18008, Spain
    • · Contact · 658011529
    • Cristobal Morales Portillo · Principal investigator
  • H.R.U Málaga - Hospital Civil
    Málaga, 29009, Spain
    • · Contact · 951290305
    • GABRIEL OLVEIRA · Principal investigator
  • Hospital Universitario Virgen Del Rocio
    Seville, 41013, Spain
    • · Contact · 955012000
    • Virginia Bellido · Principal investigator
  • Vithas Hospital Sevilla
    Seville, 41950, Spain
    • · Contact · 658011529
    • Cristobal Morales Portillo · Principal investigator
  • Hsinchu Mackay Memorial Hospital
    Hsinchu, 300, Taiwan
    • Lawrence Liu · Principal investigator
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881458
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Nov 2026 (estimated)
Primary completion
Oct 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Oct 19, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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Studies of the drugs tested here: Eloralintide · Tirzepatide

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