A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes (AMPLIFY-2)

November 2, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: LillyTrials@Lilly.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EloraTZP

Participants will receive EloraTZP subcutaneously (SC)
Drug: eloralintide and tirzepatide

Administered SC

Other Names:
  • LY900043
Experimental: Tirzepatide

Participants will receive tirzepatide SC
Drug: Tirzepatide

Administered SC

Other Names:
  • LY3298176

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 100
Baseline, Week 100

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 100
Baseline, Week 100
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 100
Baseline, Week 100
Change from Baseline in Systolic Blood Pressure
Time Frame: Baseline, Week 100
Baseline, Week 100
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time Frame: Baseline, Week 100
Baseline, Week 100
Percent Change from Baseline in Total Body Fat Mass
Time Frame: Baseline, Week 100
Baseline, Week 100
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 100
Baseline, Week 100
Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 100
Baseline, Week 100
Percentage of Participants who Achieve a Composite of Body Weight Reduction ≥ 15% and HbA1c <6.5%
Time Frame: Week 100
Week 100
Percent Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 100
Baseline, Week 100
Percent Change from Baseline in Fasting Insulin
Time Frame: Baseline, Week 100
Baseline, Week 100
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline, Week 100
Baseline, Week 100
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
Baseline, Week 100
Change from Baseline in EQ-5D-5L Score
Time Frame: Baseline, Week 100
Baseline, Week 100
Change from Baseline in Eating Behaviors and Attitudes Questionnaire (EBAQ) Score
Time Frame: Baseline, Week 100
Baseline, Week 100
Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight
Time Frame: Baseline, Week 100
Baseline, Week 100
Percentage of Participants with a Change in Medication Use
Time Frame: Baseline, Week 100
Baseline, Week 100
Overall Functional Assessment of Chronic Illness Therapy, Item GP5 (FACT-GP5) Score
Time Frame: Week 100
Week 100
Pharmacokinetics (PK): Maximum Concentration of Eloralintide at Steady State (Cmax,ss)
Time Frame: Baseline through Week 100
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)
Time Frame: Baseline through Week 100
Baseline through Week 100
PK: Maximum Concentration of Tirzepatide at Steady State (Cmax,ss)
Time Frame: Baseline through Week 100
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)
Time Frame: Baseline through Week 100
Baseline through Week 100

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27837
  • J7C-MC-YQAB (Other Identifier: Eli Lilly and Company)
  • 2026-527230-31-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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