Tirzepatide for Type 1 Diabetes and Obesity

(SURPASS-T1D-2 Trial)

Recruiting at 80 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must be taking: Insulin

Must not be taking: Weight loss drugs

Disqualifiers: Severe hypoglycemia, Pancreatitis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 18 months

465 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have used any weight loss drugs or supplements within 90 days before the trial.

What data supports the effectiveness of the drug tirzepatide for type 1 diabetes and obesity?

Tirzepatide has shown effectiveness in managing weight and improving blood sugar control in people with type 2 diabetes and obesity, as seen in clinical trials where it led to significant weight loss and better glycemic control compared to other treatments. Although this data is from type 2 diabetes studies, it suggests potential benefits for type 1 diabetes and obesity as well. ^{1 2 3 4 5}

Is tirzepatide safe for humans?

Tirzepatide has been studied for safety in people with type 2 diabetes and obesity, showing mild to moderate and temporary stomach-related side effects as the most common issues. There are some concerns about pancreatitis (inflammation of the pancreas) and gallbladder problems, but these are based on studies in type 2 diabetes and obesity. ^{1 2 3 6 7}

How is the drug tirzepatide unique for treating type 1 diabetes and obesity?

Tirzepatide is unique because it is a dual-action drug that targets both glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptors, which is different from other treatments for type 1 diabetes and obesity. This dual mechanism may offer improved blood sugar control and weight loss, which are not typically addressed together in standard treatments for type 1 diabetes. ^{1 2 3 5 8}

What is the purpose of this trial?

The main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This study is for adults with type 1 diabetes who are also overweight or obese. Participants will be involved in the trial for approximately 20 months.

Inclusion Criteria

Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening

Have an HbA1c value of 7.0% to 10.5% inclusive, 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 one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization

I have had pancreatitis before.

I haven't used weight loss drugs or supplements in the last 90 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide or placebo subcutaneously once weekly

Approximately 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Treatment Details

Interventions

• Tirzepatide

Trial Overview The trial is testing Tirzepatide, a medication, against a placebo to see its long-term effectiveness and safety in managing type 1 diabetes in individuals who are overweight or obese.

Participant Groups

Group I: Tirzepatide Experimental Treatment 1 Intervention

Participants will receive tirzepatide subcutaneously (SC)

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

In a case study of a 23-year-old female with type 1 diabetes and obesity, the use of tirzepatide led to significant improvements in glycemic control, with her time in range (TIR) increasing from 31% to 61% over 12 weeks.

The patient also experienced a reduction in daily insulin requirements from 81.9 units to 57.6 units, a decrease in hemoglobin A1c from 7.4% to 6.9%, and a weight loss of 7 pounds, suggesting that tirzepatide may be a promising treatment for managing type 1 diabetes in patients with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of tirzepatide in a patient with type 1 diabetes and obesity: A case report. Mendoza, F., Parsiani, R.[2023]

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

In a 72-week phase 3 trial involving 2539 adults with obesity, tirzepatide (5 mg, 10 mg, or 15 mg) resulted in significant weight loss, with mean reductions of -15.0%, -19.5%, and -20.9% respectively, compared to only -3.1% with placebo.

A high percentage of participants (85% to 91%) on tirzepatide achieved at least a 5% weight reduction, and many experienced improvements in cardiometabolic measures, although gastrointestinal side effects were the most common adverse events, mostly mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. Jastreboff, AM., Aronne, LJ., Ahmad, NN., et al.[2023]

Tirzepatide, administered once weekly, was found to be effective in reducing obesity in individuals with type 2 diabetes, as demonstrated in a large phase 3 trial involving multiple centers.

The study was double-blind and placebo-controlled, ensuring robust results that support tirzepatide as a promising treatment option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In adults with BMI ≥27 kg/m2 and type 2 diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. Davidson, MB.[2023]

Tirzepatide, a novel GLP-1 receptor agonist, has been shown to significantly reduce A1C levels and body weight in patients with type 2 diabetes compared to placebo and other active treatments.

The safety profile of tirzepatide is similar to other GLP-1 receptor agonists, with the most common side effects being mild to moderate gastrointestinal issues, and it does not increase the risk of hypoglycemia, making it a promising treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. Kushner, P., Anderson, JE., Simon, J., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of tirzepatide in a patient with type 1 diabetes and obesity: A case report. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

In adults with BMI ≥27 kg/m2 and type 2 diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Tirzepatide for type 2 diabetes. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety issues of tirzepatide (pancreatitis and gallbladder or biliary disease) in type 2 diabetes and obesity: a systematic review and meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Tirzepatide for the treatment of adults with type 2 diabetes: An endocrine perspective. [2023]