Tirzepatide for Type 1 Diabetes and Obesity

(SURPASS-T1D-2 Trial)

Recruiting at 93 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the efficacy and safety of tirzepatide for individuals with type 1 diabetes who are overweight or obese. Researchers aim to determine if tirzepatide can help manage blood sugar levels over an extended period. Participants will receive either tirzepatide or a placebo (an inactive substance) for comparison. Individuals who have had type 1 diabetes for at least a year, use insulin, and maintain a stable weight without recent severe blood sugar issues may qualify for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide is generally well-tolerated by people with type 1 diabetes and obesity. In one study, 32.8% of participants experienced side effects, with nausea and vomiting being the most common, affecting 22.4% of participants. Despite these side effects, 91.4% of participants continued with the treatment. This suggests that while some people may feel mild discomfort, most find the treatment manageable. Those with concerns about side effects should consult their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Type 1 diabetes, which often rely on insulin therapy, tirzepatide offers a fresh approach by acting on both the GLP-1 and GIP receptors. This dual action is believed to enhance blood sugar control and promote weight loss, which is particularly beneficial for patients with obesity. Researchers are excited because tirzepatide has shown promising results in improving metabolic health, potentially reducing the need for multiple medications. By targeting two hormone pathways at once, tirzepatide could streamline treatment, making it a potentially powerful option for managing both Type 1 diabetes and obesity.

What evidence suggests that tirzepatide might be an effective treatment for type 1 diabetes and obesity?

Research shows that tirzepatide, which participants in this trial may receive, can help people with type 1 diabetes and obesity. Studies have found it aids in weight loss, with an average reduction of about 10.9%. This treatment also helps control blood sugar, crucial for managing diabetes. In one study, patients used 21.6% less insulin, indicating better control of their condition. Overall, tirzepatide appears to be a promising option for improving both weight and blood sugar levels in this group. ^{1 2 6 7 8}

Who Is on the Research Team?

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38512447/

Efficacy and Safety of Tirzepatide in Overweight and Obese ... Conclusions: In this pilot (off label) study, we conclude that tirzepatide facilitated an average 18.5% weight loss (>46 pounds) and improved glucose control in ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2416394

Tirzepatide as Compared with Semaglutide for ... Tirzepatide was superior to semaglutide with respect to weight reduction (estimated treatment difference, −6.5 percentage points; 95% CI, −8.1 ...

3. liebertpub.com liebertpub.com/doi/full/10.1089/dtom.2025.0048

Impact of 1-Year Tirzepatide Use on Glycemic and ... Conclusions: Tirzepatide is effective in adults with T1D and obesity for improving glycemic control and promoting weight loss. It leads to a ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.70172

Weight loss in people with type 1 diabetes over 12 months ... Tirzepatide showed the greatest reduction of weight loss (10.9%; p < 0.001), followed by semaglutide (9.9%; p < 0.001) and liraglutide (7.1%; p ...

5. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/305-OR/158741/305-OR-Tirzepatide-in-Type-1-Diabetes-Safety

305-OR: Tirzepatide in Type 1 Diabetes—Safety, Tolerability ... Mean weight significantly reduced by 6.7 kg (6.7%) after 3 months (5.4-8.0 kg, p<0.001, n=36.) Mean total daily insulin dose reduced by 21.6 ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206038

Tirzepatide Once Weekly for the Treatment of Obesity In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0025619624003501

Effect of Tirzepatide on Body Weight and Diabetes Control ... Tirzepatide for the treatment of overweight and obesity in adults with T1D leads to substantial weight loss, improved diabetes control, and decreased insulin ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11571402/

Efficacy and Safety of Tirzepatide in Adults With Type 1 ... Tirzepatide significantly reduced HbA1c and body weight in adults with T1D. A randomized controlled trial is needed to establish efficacy and safety of this ...