Treatment of the disease of obesity in patients with type 1 diabetes with tirzepatide: a protocol for a randomised controlled trial in a single-centre setting

Ebaa Al Ozairi; Ameenah Al Awadhi; Etab Taghadom; Jumana Al Kandari; Dalal Alsaeed; Shaikhah Alghanim; Anant Mashankar; Carel Le Roux

doi:10.1136/bmjopen-2026-117431

Treatment of the disease of obesity in patients with type 1 diabetes with tirzepatide: a protocol for a randomised controlled trial in a single-centre setting

Ebaa Al Ozairi
, Ameenah Al Awadhi
, Etab Taghadom
, Jumana Al Kandari
, Dalal Alsaeed
, Shaikhah Alghanim
, Anant Mashankar
, Carel Le Roux

Research output: Contribution to journal › Article › peer-review

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Abstract

Introduction Medication for the disease of obesity has improved, and clinical trials based on natural gut hormones such as tirzepatide, showed only mild side effects and ~22% weight loss maintenance. However, patients with type 2 diabetes only lose 15% bodyweight with tirzepatide while tolerating the medications very well, but little is known in patients with the disease of obesity who also have type 1 diabetes, especially regarding safety of the medications. Tirzepatide’s licence in the Gulf countries and Europe for obesity does not exclude patients with obesity and type 1 diabetes, unlike the USA. In Kuwait, more than a quarter of patients with type 1 diabetes also have the disease of obesity. Tirzepatide is not approved for glycaemic control in patients with type 1 diabetes, because it is unlikely to make a difference. Because tirzepatide is approved for the treatment of obesity in patients who also have type 1 diabetes we can now test how effective treatments for obesity such as tirzepatide are for patients with obesity and type 1 diabetes. Concerns regarding the safety of the medication in type 1 diabetes can also be addressed thus addressing an important knowledge gap.

Methods and analysis This will be a randomised double blind controlled trial of 60 patients with obesity and type 1 diabetes to test usual care with or without maximum tolerable dose of tirzepatide to achieve weight loss. We will investigate the safety of the medications in patients with obesity and type 1 diabetes to address important knowledge gap which can change clinical practice.

Ethics and dissemination The study has received ethical approval from the Dasman Diabetes Institute Ethical Review Committee (HR-RA-2025-03) and is registered at ClinicalTrials.gov (NCT07096908). Written informed consent will be obtained from all participants, with no financial compensation provided. Data will be reported in accordance with Consolidated Standards of Reporting Trials guidelines, ensuring participant anonymity. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Original language	English
Article number	e117431
Journal	BMJ Open
Volume	16
Issue number	5
Early online date	7 May 2026
DOIs	https://doi.org/10.1136/bmjopen-2026-117431
Publication status	Published (in print/issue) - 7 May 2026

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/.

Data Availability Statement

De-identified participant data and study materials will be made available upon reasonable request, in accordance with institutional and regulatory guidelines.

Funding

This study is funded by Breakthrough T1D (formerly JDRF).

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

CLINICAL PHARMACOLOGY
Diabetes Mellitus, Type 1
Obesity
Weight Loss/drug effects
Humans
Tirzepatide/therapeutic use
Adult
Male
Diabetes Mellitus, Type 1/complications
Obesity/drug therapy
Randomized Controlled Trials as Topic

Access to Document

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8bf2b7cc-e6fb-4060-a33c-815183d86190Final published version, 631 KBLicence: CC BY-NC

Cite this

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title = "Treatment of the disease of obesity in patients with type 1 diabetes with tirzepatide: a protocol for a randomised controlled trial in a single-centre setting",

abstract = "Introduction Medication for the disease of obesity has improved, and clinical trials based on natural gut hormones such as tirzepatide, showed only mild side effects and \textasciitilde{}22\% weight loss maintenance. However, patients with type 2 diabetes only lose 15\% bodyweight with tirzepatide while tolerating the medications very well, but little is known in patients with the disease of obesity who also have type 1 diabetes, especially regarding safety of the medications. Tirzepatide{\textquoteright}s licence in the Gulf countries and Europe for obesity does not exclude patients with obesity and type 1 diabetes, unlike the USA. In Kuwait, more than a quarter of patients with type 1 diabetes also have the disease of obesity. Tirzepatide is not approved for glycaemic control in patients with type 1 diabetes, because it is unlikely to make a difference. Because tirzepatide is approved for the treatment of obesity in patients who also have type 1 diabetes we can now test how effective treatments for obesity such as tirzepatide are for patients with obesity and type 1 diabetes. Concerns regarding the safety of the medication in type 1 diabetes can also be addressed thus addressing an important knowledge gap. Methods and analysis This will be a randomised double blind controlled trial of 60 patients with obesity and type 1 diabetes to test usual care with or without maximum tolerable dose of tirzepatide to achieve weight loss. We will investigate the safety of the medications in patients with obesity and type 1 diabetes to address important knowledge gap which can change clinical practice. Ethics and dissemination The study has received ethical approval from the Dasman Diabetes Institute Ethical Review Committee (HR-RA-2025-03) and is registered at ClinicalTrials.gov (NCT07096908). Written informed consent will be obtained from all participants, with no financial compensation provided. Data will be reported in accordance with Consolidated Standards of Reporting Trials guidelines, ensuring participant anonymity. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.",

keywords = "CLINICAL PHARMACOLOGY, Diabetes Mellitus, Type 1, Obesity, Weight Loss/drug effects, Humans, Tirzepatide/therapeutic use, Adult, Male, Diabetes Mellitus, Type 1/complications, Obesity/drug therapy, Randomized Controlled Trials as Topic",

author = "\{Al Ozairi\}, Ebaa and \{Al Awadhi\}, Ameenah and Etab Taghadom and \{Al Kandari\}, Jumana and Dalal Alsaeed and Shaikhah Alghanim and Anant Mashankar and \{Le Roux\}, Carel",

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/.",

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volume = "16",

journal = "BMJ Open",

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T1 - Treatment of the disease of obesity in patients with type 1 diabetes with tirzepatide: a protocol for a randomised controlled trial in a single-centre setting

AU - Al Ozairi, Ebaa

AU - Al Awadhi, Ameenah

AU - Taghadom, Etab

AU - Al Kandari, Jumana

AU - Alsaeed, Dalal

AU - Alghanim, Shaikhah

AU - Mashankar, Anant

AU - Le Roux, Carel

N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: https://creativecommons.org/licenses/by-nc/4.0/.

PY - 2026/5/7

Y1 - 2026/5/7

N2 - Introduction Medication for the disease of obesity has improved, and clinical trials based on natural gut hormones such as tirzepatide, showed only mild side effects and ~22% weight loss maintenance. However, patients with type 2 diabetes only lose 15% bodyweight with tirzepatide while tolerating the medications very well, but little is known in patients with the disease of obesity who also have type 1 diabetes, especially regarding safety of the medications. Tirzepatide’s licence in the Gulf countries and Europe for obesity does not exclude patients with obesity and type 1 diabetes, unlike the USA. In Kuwait, more than a quarter of patients with type 1 diabetes also have the disease of obesity. Tirzepatide is not approved for glycaemic control in patients with type 1 diabetes, because it is unlikely to make a difference. Because tirzepatide is approved for the treatment of obesity in patients who also have type 1 diabetes we can now test how effective treatments for obesity such as tirzepatide are for patients with obesity and type 1 diabetes. Concerns regarding the safety of the medication in type 1 diabetes can also be addressed thus addressing an important knowledge gap. Methods and analysis This will be a randomised double blind controlled trial of 60 patients with obesity and type 1 diabetes to test usual care with or without maximum tolerable dose of tirzepatide to achieve weight loss. We will investigate the safety of the medications in patients with obesity and type 1 diabetes to address important knowledge gap which can change clinical practice. Ethics and dissemination The study has received ethical approval from the Dasman Diabetes Institute Ethical Review Committee (HR-RA-2025-03) and is registered at ClinicalTrials.gov (NCT07096908). Written informed consent will be obtained from all participants, with no financial compensation provided. Data will be reported in accordance with Consolidated Standards of Reporting Trials guidelines, ensuring participant anonymity. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.

AB - Introduction Medication for the disease of obesity has improved, and clinical trials based on natural gut hormones such as tirzepatide, showed only mild side effects and ~22% weight loss maintenance. However, patients with type 2 diabetes only lose 15% bodyweight with tirzepatide while tolerating the medications very well, but little is known in patients with the disease of obesity who also have type 1 diabetes, especially regarding safety of the medications. Tirzepatide’s licence in the Gulf countries and Europe for obesity does not exclude patients with obesity and type 1 diabetes, unlike the USA. In Kuwait, more than a quarter of patients with type 1 diabetes also have the disease of obesity. Tirzepatide is not approved for glycaemic control in patients with type 1 diabetes, because it is unlikely to make a difference. Because tirzepatide is approved for the treatment of obesity in patients who also have type 1 diabetes we can now test how effective treatments for obesity such as tirzepatide are for patients with obesity and type 1 diabetes. Concerns regarding the safety of the medication in type 1 diabetes can also be addressed thus addressing an important knowledge gap. Methods and analysis This will be a randomised double blind controlled trial of 60 patients with obesity and type 1 diabetes to test usual care with or without maximum tolerable dose of tirzepatide to achieve weight loss. We will investigate the safety of the medications in patients with obesity and type 1 diabetes to address important knowledge gap which can change clinical practice. Ethics and dissemination The study has received ethical approval from the Dasman Diabetes Institute Ethical Review Committee (HR-RA-2025-03) and is registered at ClinicalTrials.gov (NCT07096908). Written informed consent will be obtained from all participants, with no financial compensation provided. Data will be reported in accordance with Consolidated Standards of Reporting Trials guidelines, ensuring participant anonymity. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.

KW - CLINICAL PHARMACOLOGY

KW - Diabetes Mellitus, Type 1

KW - Obesity

KW - Weight Loss/drug effects

KW - Humans

KW - Tirzepatide/therapeutic use

KW - Adult

KW - Male

KW - Diabetes Mellitus, Type 1/complications

KW - Obesity/drug therapy

KW - Randomized Controlled Trials as Topic

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DO - 10.1136/bmjopen-2026-117431

M3 - Article

C2 - 42097660

SN - 2044-6055

VL - 16

JO - BMJ Open

JF - BMJ Open

IS - 5

M1 - e117431

ER -

Treatment of the disease of obesity in patients with type 1 diabetes with tirzepatide: a protocol for a randomised controlled trial in a single-centre setting

Abstract

Bibliographical note

Data Availability Statement

Funding

UN SDGs

Keywords

Access to Document

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