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Could a higher dose of tirzepatide tackle diabetes and obesity together?

NCT ID NCT06037252

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests different doses of tirzepatide in 414 adults with type 2 diabetes and obesity who already take metformin. The goal is to see if the drug helps with weight loss and blood sugar control. Participants receive either tirzepatide or a placebo for about 89 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirzepatide
What this could lead to
If successful, this could lead to a new treatment option that helps people with type 2 diabetes and obesity lose weight and better control their blood sugar.
What could go wrong
This is a phase 2 trial, so it's still early. The drug may not work better than placebo, and side effects are possible. Results may not apply to everyone with diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

414 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

Body Weight diabetes mellitus endocrine system disorder glucose metabolism disease metabolic disease nutritional disorder Obesity obesity disorder overnutrition type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Type 2 diabetes

Contacts and locations

Locations

  • AGILE Clinical Research Trials, LLC

    Sandy Springs, Georgia, 30328, United States

  • Accellacare - Wilmington - 1917 Tradd Court

    Wilmington, North Carolina, 28401, United States

  • Acibadem Universitesi Atakent Hastanesi

    Istanbul, 34303, Turkey (Türkiye)

  • Akdeniz Universitesi Hastanesi

    Antalya, 07070, Turkey (Türkiye)

  • Alta Pharmaceutical Research Center

    Norcross, Georgia, 30092, United States

  • American Research Centers of Florida

    Pembroke Pines, Florida, 33027, United States

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

    Adana, 01250, Turkey (Türkiye)

  • CEDIC

    CABA, Buenos Aires, C1060ABN, Argentina

  • Care Access - Aurora

    Aurora, Colorado, 80012, United States

  • Care Access - Sacramento

    Sacramento, California, 95831, United States

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

    Mexico City, Mexico City, 11650, Mexico

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, Buenos Aires F.D., C1425AGC, Argentina

  • Centro Médico Viamonte

    Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina

  • Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

    Ciudad Madero, Tamaulipas, 89440, Mexico

  • Centro de Investigacion Cardiovascular y Metabólica

    Tijuana, Estado de Baja California, 22500, Mexico

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI, Argentina

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911, United States

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708, United States

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203, United States

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1405, Argentina

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

    Cuauhtémoc, Ciudad de México, Mexico City, 06100, Mexico

  • Dicle Üniversitesi

    Diyarbakır, 21100, Turkey (Türkiye)

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310, Turkey (Türkiye)

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460, Mexico

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265, United States

  • John Muir Physician Network Research Center

    Concord, California, 94520, United States

  • Juno Research

    Houston, Texas, 77040, United States

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Istanbul, 34899, Turkey (Türkiye)

  • Medical Advancement Centers of Arizona

    Phoenix, Arizona, 85044, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ondokuz Mayıs Universitesi

    Samsun, 55139, Turkey (Türkiye)

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715, United States

  • Retreat Medical Research

    Miami, Florida, 33135, United States

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149, United States

  • Summit Headlands

    Portland, Oregon, 97210, United States

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

    Kadıköy, Istanbul, 34722, Turkey (Türkiye)

  • Uludag Universitesi

    Bursa, 16059, Turkey (Türkiye)

  • Velocity Clinical Research, Mt. Auburn

    Cincinnati, Ohio, 45219, United States

  • Virgen Cardiovascular Research SC

    Guadalajara, Jalisco, 44670, Mexico

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