Tirzepatide for Type 1 Diabetes and Obesity

(SURPASS-T1D-1 Trial)

Recruiting at 173 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: 49 weeks

905 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new drug, tirzepatide, for individuals with both type 1 diabetes and obesity. Researchers aim to determine if this medication can manage blood sugar levels safely. Participants will receive varying doses of tirzepatide or a placebo (a substance with no active drug) for comparison. Ideal candidates have used insulin for at least a year, maintain a stable weight, and do not plan major lifestyle changes. As a Phase 3 trial, this study is the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

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.

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 one study, about 32.8% of participants experienced side effects, with nausea or vomiting being the most common at 22.4%. Despite these side effects, 91.4% of participants continued the treatment, indicating that most found the side effects manageable.

Moreover, tirzepatide has approval for other conditions, providing some reassurance about its safety. However, like any medication, it may cause side effects in some individuals. Always consult a doctor to determine if it's suitable. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for type 1 diabetes?

Tirzepatide is unique because it combines the effects of two hormones, GLP-1 and GIP, to help regulate blood sugar and promote weight loss. Unlike standard treatments for type 1 diabetes, which typically involve insulin therapy, tirzepatide offers an innovative approach by targeting these hormones to improve metabolic control. Additionally, its potential to address both diabetes and obesity simultaneously sets it apart from existing options, providing a dual benefit for patients. Researchers are excited about tirzepatide because it could offer a new way to manage these conditions more effectively, with fewer side effects and improved patient outcomes.

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

Research has shown that tirzepatide can significantly benefit people with type 1 diabetes and obesity. Past patients have experienced improved blood sugar control and notable weight loss. One study found that participants lost about 18.5% of their body weight, averaging over 46 pounds. Another study reported a 10.9% weight loss over a year with tirzepatide. Additionally, the total insulin required decreased, indicating better diabetes management. These findings suggest tirzepatide could be a promising option for managing both weight and diabetes. Participants in this trial will receive varying doses of tirzepatide or a placebo to further evaluate its effectiveness. ^{1 2 4 6 7}

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 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 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

49 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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, 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]

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 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 At 20 weeks after randomization, treatment with tirzepatide resulted in a significantly greater weight reduction than that with placebo (Table 3) ...

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 ...