Tirzepatide for Type 1 Diabetes and Obesity

(SURPASS-T1D-1 Trial)

Recruiting at 148 trial locations

Overseen By Bruce Bode

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: 49 weeks

905 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have used any weight loss drugs or supplements within 90 days before starting. It's best to discuss your current medications with the trial team.

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 demonstrated in clinical trials. Although these results are for type 2 diabetes, they suggest potential benefits for people with 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 stomach-related side effects like nausea. There are some concerns about pancreatitis (inflammation of the pancreas) and gallbladder issues, but these are not common. ^{2 3 4 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 (GIP) and glucagon-like peptide-1 (GLP-1) receptors, which is different from other treatments that typically target only one of these pathways. This dual mechanism may offer enhanced benefits in managing blood sugar levels and weight, making it a novel option for people with type 1 diabetes and obesity. ^{2 3 4 5 8}

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 trial is for adults with type 1 diabetes who are also overweight or obese. Participants will be involved in the study for approximately 49 weeks.

Inclusion Criteria

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

Have an HbA1c value of 7.0% to 10.5% inclusive, at screening

Exclusion Criteria

Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization

I've been hospitalized twice for poor blood sugar control in the last 6 months.

I am being treated for diabetic eye problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide or placebo subcutaneously once weekly

49 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tirzepatide

Trial Overview The study is testing the effectiveness and safety of a medication called Tirzepatide compared to a placebo, which has no active ingredients.

Participant Groups

Group I: Tirzepatide Dose 4 Experimental Treatment 1 Intervention

Participants will receive tirzepatide SC

Group II: Tirzepatide Dose 3 Experimental Treatment 1 Intervention

Participants will receive tirzepatide SC

Group III: Tirzepatide Dose 2 Experimental Treatment 1 Intervention

Participants will receive tirzepatide SC

Group IV: Tirzepatide Dose 1 Experimental Treatment 1 Intervention

Participants will receive tirzepatide subcutaneously (SC)

Group V: 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

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]

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, 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

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

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

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

3. 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]

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

Tirzepatide Once Weekly for the Treatment of Obesity. [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]