18 Participants NeededMy employer runs this trial

Tirzepatide for Type 1 Diabetes and Obesity

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
Must be taking: Insulin

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new treatment, tirzepatide, affects stomach emptying in individuals with Type 1 Diabetes who are overweight or obese. Researchers aim to determine if this medication, combined with acetaminophen (a common pain reliever), can better manage these conditions. Participants are divided into two groups: one receives tirzepatide and acetaminophen, while the other receives a placebo (inactive substance) and acetaminophen. Suitable candidates have had Type 1 Diabetes for at least a year, use insulin, have a BMI of 25 or more, and have not significantly changed their weight in the past three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tirzepatide is generally well-tolerated. In earlier studies, most side effects were mild to moderate, with the most common being stomach-related issues like nausea, affecting 12-18% of participants. These symptoms were temporary and often resolved on their own.

Additionally, tirzepatide has proven safe in real-world use. People taking the drug experienced weight loss and required less insulin. However, there is a higher risk of severe low blood sugar in some cases, so careful monitoring remains important.

It is important to note that tirzepatide is not approved for Type 1 diabetes or for treating diabetic ketoacidosis, a serious diabetes complication. Always consult a doctor when considering this treatment.12345

Why do researchers think this study treatment might be promising for Type 1 Diabetes?

Researchers are excited about tirzepatide for Type 1 Diabetes and obesity because it offers a novel approach by acting as a dual agonist on the receptors for both GLP-1 and GIP, hormones involved in regulating blood sugar and appetite. This is different from current treatments, which primarily focus on insulin therapy for Type 1 Diabetes and various drugs or lifestyle changes for obesity. By targeting these specific hormone pathways, tirzepatide has the potential to improve blood sugar control and aid in weight loss more effectively and efficiently than existing options.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes and Obesity?

Research has shown that tirzepatide may aid in weight management and type 2 diabetes. It mimics hormones that regulate blood sugar and appetite. Previous users have experienced weight loss and improved blood sugar levels. For individuals with obesity, it reduces appetite, aiding weight loss. In this trial, participants will receive either tirzepatide with acetaminophen or a placebo with acetaminophen to assess its effects on weight and blood sugar in those with type 1 diabetes and obesity. Although limited information exists for type 1 diabetes, its potential impact on weight and blood sugar could be beneficial.678910

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with type 1 diabetes who are also overweight or obese. Participants should be generally healthy aside from their diabetes and weight, and able to follow study procedures.

Inclusion Criteria

Are of stable weight, that is a self-reported change of 5 kg or less, for at least 90 days prior to screening
Have a body mass index (BMI) greater than or equal to 25.0 kilograms per square meter (kg/m2) at screening
I have type 1 diabetes and have used insulin for at least one year.

Exclusion Criteria

I am allergic or intolerant to acetaminophen, tirzepatide, or GLP-1 drugs.
I have a diagnosed problem with how my stomach empties food.
I have had weight loss surgery like gastric bypass or a similar procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either tirzepatide or placebo administered subcutaneously, along with acetaminophen administered orally

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-3 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tirzepatide

Trial Overview

The study tests tirzepatide (a medication given by injection) compared to a placebo, sometimes alongside acetaminophen, to see how it affects stomach emptying in people with type 1 diabetes and excess weight. The study lasts about 8 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Tirzepatide + AcetaminophenExperimental Treatment2 Interventions
Group II: Placebo + AcetaminophenPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

Diabetes Basics

Diabetes is a chronic (long-lasting) health condition that affects how your body turns food into energy. There are three main types of diabetes: type 1, type 2, ...

2.

diabetes.org

diabetes.org/

Diabetes Research, Education, Advocacy | ADA

Leading the fight against the deadly consequences of diabetes for those affected by it through research funding, community services, education and advocacy.

Obesity: Prevalence, causes, consequences, management ...

Several antiobesity drugs are approved for long-term treatment, with effectiveness and safety differing between them (Table 1). Table 1. Obesity treatment drugs ...

Diabetes

Diabetes factsheet from WHO providing key facts and information on types of diabetes, symptoms, common consequences, economic impact, ...

Obesity - Symptoms and causes

Study identifies patients with obesity most likely to benefit from GLP-1-based treatment. Show more news from Mayo Clinic. Products & Services.

Real-World 12-Month Weight Loss Outcomes of Tirzepatide ...

Compared to patients without T2D, those with T2D lost less weight at 12 months: -14±9% vs. -19±9%, p=0.01.

Psychiatric Safety of Tirzepatide in People With Obesity ...

In the SURMOUNT clinical trial program, robust weight reduction was observed with once weekly tirzepatide treatment, a once weekly dual GIP/GLP- ...

Efficacy and safety of tirzepatide, GLP‐1 receptor agonists, ...

Primary outcomes were adverse events (AEs) and serious AEs. tirzepatide showed a higher severe hypoglycemia risk (<54 mg/dL).

Tirzepatide proves safety, efficacy in T1D in real world

The use of tirzepatide in a real-world setting demonstrates a favourable safety profile and results in weight loss, lower insulin.

Tirzepatide For Weight Loss And Diabetes Control.

It is also not intended for type 1 diabetes or for treating diabetic ketoacidosis. People with a history of pancreatitis, severe gastrointestinal disease … ...