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Could a weekly shot help type 1 diabetes patients shed pounds and control blood sugar?

NCT ID NCT06962280

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests tirzepatide, a once-weekly injection, in 465 adults with type 1 diabetes who are also overweight or obese. Participants receive either tirzepatide or a placebo for about 20 months. The study measures changes in blood sugar control (HbA1c) and body weight to see if the drug offers long-term benefits beyond insulin.

What this could mean

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

Active substance
tirzepatide (a once-weekly injection)
What this could lead to
If it works, tirzepatide could become a new option to help people with type 1 diabetes and excess weight better control their blood sugar and lose weight.
What could go wrong
This is a phase 3 trial, but results are not yet available. Tirzepatide is already approved for type 2 diabetes, but its safety and effectiveness in type 1 diabetes are still being studied. Possible side effects include gastrointestinal issues.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 465 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jul 2027

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 years and older

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 type 1 diabetes and on insulin treatment for at least one year prior to screening * Have an HbA1c value of 7.0% to 10.5% inclusive, at screening * Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening * Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study Exclusion Criteria: * Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization. * Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization. * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have had chronic or acute pancreatitis * Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 1 diabetes mellitus

As listed by the trial registrant

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

Obesity Overweight Type 1 diabetes

Contacts and locations

Locations

  • AIDIN VK s.r.o.

    Hranice, 753 01, Czechia

  • AMCR Institute

    Escondido, California, 92025, United States

  • Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière

    Paris, 75010, France

  • Athens Medical Center

    Athens, 151 25, Greece

  • Buenos Aires Macula S.A

    Buenos Aires, 1061, Argentina

  • CEINV Salud

    Monterrey, 64020, Mexico

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010, Brazil

  • CHU Rangueil

    Toulouse, 31059, France

  • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

    Godoy Cruz, M5501ARP, Argentina

  • CMI DNBM Dr. Pop Lavinia

    Baia Mare, 430222, Romania

  • CPCLIN

    São Paulo, 01228-200, Brazil

  • Care Access - Cape Breton

    Sydney, B1M 0A1, Canada

  • Cendi - Endocrinologia e Diabetes

    Goiânia, 74230-035, Brazil

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91106, France

  • Centre Hospitalier Universitaire - Hôpitaux de Rouen - Hôpital de Bois-Guillaume

    Bois-Guillaume, 76230, France

  • Centre Hospitalier Universitaire de Grenoble

    Grenoble, 38700, France

  • Centre de Recherche Saint-Louis

    Sherbrooke, J1G 1X9, Canada

  • Centricity Research Ottawa LMC Endocrinology

    Ottawa, K2J 0V2, Canada

  • Centro Diabetológico Dr. Waitman

    Córdoba, 5000, Argentina

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, 2152, Argentina

  • Centro de Pesquisa Clinica do Brasil

    Brasília, 71625-175, Brazil

  • Centro de Pesquisa Sao Lucas

    Campinas, 13060-803, Brazil

  • Centrul Medical Consultmed

    Iași, 700547, Romania

  • Centrul medical DiabNutriMed

    Bucharest, 020359, Romania

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005, United States

  • Clinvest Headlands Llc

    Springfield, Missouri, 65807, United States

  • Clínica García Flores SC

    Monterrey, 64610, Mexico

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla City, 72190, Mexico

  • Diabet Med

    Bucharest, 050913, Romania

  • Diabetologicke centrum s.r.o.

    Olomouc, 779 00, Czechia

  • Diamed Obesity

    Galați, 800291, Romania

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua City, 31110, Mexico

  • Endocrinologie Oasis

    Montreal, H4J 1E3, Canada

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 546 45, Greece

  • Groupe Hospitalier Mutualiste Les Portes du Sud

    Vénissieux, 69200, France

  • HealthPartners Institute dba International Diabetes Center

    Minneapolis, Minnesota, 55416, United States

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Infanta Cristina

    Badajoz, 06080, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hôpital de la Conception

    Marseille, 13005, France

  • Hôtel-Dieu du Creusot - site Harfleur

    Le Creusot, 71200, France

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180, Brazil

  • INTENDIA klinika s.r.o.

    Chrudim III, 537 01, Czechia

  • Iatriko Paleou Falirou Medical Center

    Palaió Fáliro, 17562, Greece

  • Instituto Médico Catamarca IMEC

    Rosario, 2000, Argentina

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080, Mexico

  • Instituto da Crianca com Diabetes

    Porto Alegre, 91350-250, Brazil

  • Investigaciones Clínicas Tucumán

    San Miguel de Tucumán, T4000ICL, Argentina

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50266, United States

  • Ippokrateio General Hospital of Thessaloniki

    Thessaloniki, 54642, Greece

  • Juno Research

    Houston, Texas, 77040, United States

  • Kaiser Permanente Bonita Medical Offices

    Bonita, California, 91902, United States

  • Las Vegas Endocrinology

    Henderson, Nevada, 89074, United States

  • MUDr. Tomas Edelsberger

    Krnov, 79401, Czechia

  • Mariodiab Clinic

    Brasov, 500097, Romania

  • Mary & Dick Allen Diabetes Center

    Newport Beach, California, 92663, United States

  • Mautalen Salud e Investigación

    Buenos Aires, C1128AAF, Argentina

  • Medsal Centro Médico

    Tampico, 89210, Mexico

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401, United States

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Prague, 14900, Czechia

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, 44670, Mexico

  • Quanta Diagnóstico e Terapia

    Curitiba, 80045170, Brazil

  • ResTrial s.r.o.

    Prague, 18100, Czechia

  • Rinart Diab SRL

    Targoviste, 130168, Romania

  • San Antonio Clinical Trials

    San Antonio, Texas, 78240, United States

  • Sanamed Hospital

    Bucharest, 060013, Romania

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149, United States

  • Stat Research S.A.

    Buenos Aires, C1023AAB, Argentina

  • TLC Diabetes and Endocrinology

    Surrey, V3T 2V6, Canada

  • Texas Diabetes & Endocrinology, P.A.

    Round Rock, Texas, 78681, United States

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596, United States

  • Unidad de Investigación Clínica y Atención Médica HEPA S.C.

    Guadalajara, 44670, Mexico

  • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

    Guadalajara, 44150, Mexico

  • University Clinical Investigators, Inc.

    Tustin, California, 92780, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514, United States

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230, United States

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Other studies related to the condition(s) this trial covers.