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Type 2 DiabetesPhase 2NCT06037252

A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

A Phase 2 study testing Tirzepatide in people with Type 2 Diabetes and Obesity, run by Eli Lilly and Company at 40 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes, Obesity
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
414 participants
Where
40 sitesin 4 countries
Study dates
21 Sep 2023to Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening.
  • Have had stable body weight (±5%) during the 90 days preceding screening.
  • Have been diagnosed with Type 2 Diabetes (T2D).
  • Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.

Who cannot join

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
  • Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
  • Have a prior or planned surgical treatment for obesity.
  • Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.
  • Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliter/min (mL/min)/1.73 m².
Show all 14Show fewer
  • Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.
  • acute myocardial infarction.
  • cerebrovascular accident (stroke).
  • unstable angina .
  • hospitalization due to congestive heart failure, or
  • coronary artery revascularization.
  • Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
  • Have a history of chronic or acute pancreatitis.

Trial locations and contacts

40 sites in 4 countries.

40 sites in 4 countries

United States20 sites

  • Care Access - Aurora

    Aurora, Colorado, 80012

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Northwestern University

    Chicago, Illinois, 60611

  • Velocity Clinical Research, Mt. Auburn

    Cincinnati, Ohio, 45219

  • John Muir Physician Network Research Center

    Concord, California, 94520

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715

  • Juno Research

    Houston, Texas, 77040

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • Retreat Medical Research

    Miami, Florida, 33135

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203

  • Alta Pharmaceutical Research Center

    Norcross, Georgia, 30092

  • American Research Centers of Florida

    Pembroke Pines, Florida, 33027

  • Medical Advancement Centers of Arizona

    Phoenix, Arizona, 85044

  • Summit Headlands

    Portland, Oregon, 97210

  • Care Access - Sacramento

    Sacramento, California, 95831

  • AGILE Clinical Research Trials, LLC

    Sandy Springs, Georgia, 30328

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Accellacare - Wilmington - 1917 Tradd Court

    Wilmington, North Carolina, 28401

Other trials in United States

Turkey (Türkiye)9 sites

  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

    Adana, 01250

  • Akdeniz Universitesi Hastanesi

    Antalya, 07070

  • Uludag Universitesi

    Bursa, 16059

  • Dicle Üniversitesi

    Diyarbakır, 21100

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310

  • Acibadem Universitesi Atakent Hastanesi

    Istanbul, 34303

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Istanbul, 34899

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Kadıköy, Istanbul, 34722

  • Ondokuz Mayıs Universitesi

    Samsun, 55139

Other trials in Turkey (Türkiye)

Mexico6 sites

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Ciudad Madero, Tamaulipas, 89440

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Ciudad de México, Mexico City, 06100

  • Virgen Cardiovascular Research SC

    Guadalajara, Jalisco, 44670

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, Mexico City, 11650

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460

  • Centro de Investigacion Cardiovascular y Metabólica

    Tijuana, Estado de Baja California, 22500

Other trials in Mexico

Argentina5 sites

  • Centro Médico Viamonte

    Buenos Aires, Buenos Aires F.D., C1120AAC

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, Buenos Aires F.D., C1425AGC

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

  • CEDIC

    CABA, Buenos Aires, C1060ABN

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1405

Other trials in Argentina

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Read the detailed description

The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.

Being tested
Tirzepatide, Placebo
Keywords
Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Overnutrition, Nutrition Disorders, Body Weight, Tirzepatide, Incretins
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Overnutrition, Nutrition Disorders

What participants receive

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

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT06037252
Study groupRoleWhat they receive
Tirzepatide High Dose 1ExperimentalParticipants will receive tirzepatide subcutaneously (SC).
Receives: Drug: Tirzepatide
Tirzepatide High Dose 2ExperimentalParticipants will receive tirzepatide SC.
Receives: Drug: Tirzepatide
TirzepatideActive comparatorParticipants will receive tirzepatide SC.
Receives: Drug: Tirzepatide
PlaceboPlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo

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 0), Week 44

Secondary outcomes (12)

  1. Change from Baseline in HbA1c

    Measured: Baseline (Week 0), Week 44

  2. Change from Baseline in HbA1c

    Measured: Baseline (Week 24), Week 80

  3. Percent Change from Baseline in Body Weight

    Measured: Baseline (Week 24), Week 80

  4. Absolute Change from Baseline in Body Weight

    Measured: Baseline (Week 0), Week 44

  5. Absolute Change from Baseline in Body Weight

    Measured: Baseline (Week 24), Week 80

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

    Measured: Baseline (Week 0), Week 44

  7. Change from Baseline in BMI

    Measured: Baseline (Week 24), Week 80

  8. Change from Baseline in Waist Circumference

    Measured: Baseline (Week 0), Week 44

  9. Change from Baseline in Waist Circumference

    Measured: Baseline (Week 24), Week 80

  10. Percentage of Participants Achieving ≥15% Body Weight Reduction

    Measured: Baseline (Week 0), Week 44

  11. Percentage of Participants Achieving ≥15% Body Weight Reduction

    Measured: Baseline (Week 0), Week 80

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

    Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.

    Measured: Baseline through Week 44

Timeline

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

  1. First posted14 Sep 2023
  2. Study start21 Sep 2023
  3. Primary completion8 Jan 2026
  4. Study completionOct 2026 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06037252
Sponsor's protocol ID
18739
Other IDs
I8F-MC-GPIT, 2023-504561-24-00, 2023
Status last verified
Mar 2026
First submitted
8 Sep 2023
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide in people with Type 2 Diabetes and Obesity, run by Eli Lilly and Company at 40 sites in 4 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 4 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Turkey (Türkiye), Mexico, Argentina. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 0), Week 44). 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 NCT06037252.

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 23 Mar 2026.

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