Efficacy and Safety of Tirzepatide in Adults with Type 1 Diabetes Who Are Overweight or Obese

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What is this study about?

The study focuses on adults who have Type 1 Diabetes and are also classified as Obesity or Overweight. They will receive a weekly injection of tirzepatide (LY3298176) or a placebo. The purpose is to determine whether the medication can provide better control of blood sugar levels compared with the placebo.

Participants will be given the assigned injection once each week for about 40 weeks. During the study they will attend regular clinic visits where a simple blood test called Hemoglobin A1c (HbA1c) will be used to measure average blood sugar over the past few months, along with routine safety checks. The study is designed so that neither the participants nor the study staff know which injection is being given, helping to keep the results unbiased.

1 enrollment and baseline assessment

after joining the study, you will complete a consent form and undergo initial health measurements, including weight, blood sugar level, and other routine tests.

these baseline results will be used to compare later changes during the trial.

2 randomization and receipt of study medication

you will be assigned by the study system to receive either tirzepatide or a placebo that looks identical.

the medication is provided in a pre‑filled pen for subcutaneous use (injection under the skin).

the label indicates a dose of 0 mg; the exact amount to be injected is determined by the study protocol and delivered in the pen.

3 training on injection technique

study staff will teach you how to perform a subcutaneous injection using the pre‑filled pen.

you will practice the technique under supervision to ensure correct use.

4 first weekly injection

the first injection of tirzepatide or placebo is given once a week, starting in week 1.

the injection is administered under the skin, typically in the abdomen, thigh, or upper arm.

5 continuous weekly injections

you will continue to inject the study medication once every week for the duration of the trial, which extends to week 40.

each dose is the same as the initial dose provided in the pre‑filled pen.

6 scheduled clinic visits for monitoring

clinic visits are scheduled at weeks 4, 12, 24, and 40.

during each visit, staff will check your weight, blood pressure, and any side effects.

blood samples will be taken to measure hemoglobin a1c, a marker of long‑term blood sugar control.

7 final assessment at week 40

at the end of week 40, a comprehensive evaluation is performed.

the primary outcome is the change in hemoglobin a1c from the baseline measurement.

additional safety assessments are also completed before the study concludes.

Who Can Join the Study?

  • Be at least 18 years old.
  • Have type 1 diabetes – a condition where the body does not produce enough insulin, a hormone that controls blood sugar.
  • Have been using insulin treatment for at least one year.
  • Have blood sugar levels, called blood glucose, that fall within the range allowed by the study.
  • Be classified as obese (very high body weight) or overweight (higher than normal body weight).
  • Be either male or female, as both genders are accepted.
  • People considered vulnerable (who may need extra protection) are allowed to participate.

Who Cannot Join the Study?

  • You have been admitted to the hospital two or more times in the past six months because your blood sugar was extremely high (also called very high blood glucose).
  • You have needed emergency medical care one or more times in the past three months because your blood sugar was very low (also called very low blood glucose).
  • You are currently receiving or plan to receive treatment for diabetic eye disease, which means eye problems caused by diabetes.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia Baia Mare Romania

Other Sites

Site Name City Country Status
Consultmed S.R.L. Iasi Romania
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Universitaire Rouen Rouen France
ResTrial s.r.o. Prague Czechia
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hopital Beaujon Clichy France
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Centre De Recherche Clinique Portes Du Sud Venissieux France
Mariodiab Clinic S.R.L. Brasov Romania
Diamed Obesity S.R.L. Galati Romania
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
INTENDIA klinika s.r.o. Chrudim Czechia
Rinart Diab S.R.L. Targoviste Romania
Aidin VK s.r.o. Hranice I-Mesto Czechia
Diabetologicke centrum s.r.o. Olomouc Czechia
MUDr. Tomáš Edelsberger, Diabetologie Krnov Czechia
Mywpr Kwguiu ssvflj Prague Czechia
Cpmfevf Dkmcdqccwseo Stksle Bucharest Romania
Sdnplze Hsbdfpmw Sjnfqz Bucharest Romania
Agqpxg Mnmkzxy Cguenl Smab Thessaloniki Greece
Hbyovech Uhofimmauxoyc Dq Bewiovf Badajoz Spain
Dthxld Mge Svxgvx Bucharest Romania
Hinhcyex Uzijzlxxyexzg Hvzsijnt Tprbk y Pogtxq Iscjlwxt Cqytrh dyqgftgpuudahamwd (wpjc Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
30.06.2025
France France
Not recruiting
30.06.2025
Greece Greece
Not recruiting
30.06.2025
Romania Romania
Not recruiting
30.06.2025
Spain Spain
Not recruiting
30.06.2025

Trial locations

Investigated drugs:

Tirzepatide is a medication that is given as a liquid injection under the skin using a pre‑filled pen. In this study participants will receive it once a week. The drug is being tested to see if it can improve blood sugar control better than a placebo in adults who have type 1 diabetes and are overweight or obese. Researchers will also watch for any safety concerns while participants take the medication over a long period.

Investigated diseases:

Obesity – A condition in which a person has an excess amount of body fat, usually defined by a body‑mass index (BMI) of 30 or higher. It develops gradually when the amount of calories taken in consistently exceeds the amount used for energy. Over time, the extra calories are stored as fat, leading to steady weight gain. As the body adapts, losing the added weight can become increasingly difficult. The condition often persists and may become more pronounced if the imbalance continues.

Overweight – A state where a person’s body weight is higher than what is considered normal, typically indicated by a BMI between 25 and 29.9. It arises when energy intake is slightly higher than energy expenditure. Weight usually increases slowly, adding extra fat around the body. If the excess calorie intake continues, the condition can progress to obesity.

Type 1 diabetes – A disease in which the pancreas stops producing enough insulin, a hormone needed to move sugar from the blood into cells. It most often begins in childhood or early adulthood. Without sufficient insulin, blood sugar levels rise and remain high. Over time, the body’s ability to regulate glucose becomes increasingly impaired. The condition typically remains stable but may require ongoing adjustments as the body changes.

Trial ID:
2024-519685-51-00
Protocol code:
I8F-MC-GPJD
Trial Phase:
Therapeutic confirmatory (Phase III)

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