Tirzepatide for Type 2 Diabetes

No longer recruiting at 36 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Eli Lilly and Company

Must be taking: GLP-1 RAs

Disqualifiers: Type 1 diabetes, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how switching to a new medication, tirzepatide (a GIP/GLP-1 receptor agonist), affects individuals with type 2 diabetes. The focus is on those currently taking a GLP-1 RA diabetes medication to determine if tirzepatide can better manage their blood sugar. Eligible participants must have type 2 diabetes, have been on a stable GLP-1 RA treatment for at least three months, and use no more than three oral diabetes medications. They should have an HbA1c level (a measure of blood sugar over time) between 6.5% and 9.0% and a BMI of 25 or higher. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how tirzepatide benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have been on a stable dose of a GLP-1 RA for at least 3 months and can be on stable doses of up to 3 oral antidiabetic medicines.

What is the safety track record for tirzepatide?

Research shows that the FDA has approved tirzepatide for treating type 2 diabetes, indicating it has undergone safety testing in people. Some studies have also examined its safety for weight loss and found that participants generally tolerated tirzepatide well.

However, some side effects have been reported. Common ones include nausea and diarrhea, usually mild to moderate. While researchers continue to collect real-world safety data, the FDA's approval for diabetes treatment provides some confidence in its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tirzepatide is unique because it combines the actions of two hormones, GIP and GLP-1, to help control blood sugar levels in people with Type 2 diabetes. Unlike standard treatments like metformin or GLP-1 receptor agonists, which typically focus on just one hormone pathway, tirzepatide targets both, potentially offering more comprehensive glucose control. Researchers are excited about this treatment because it could improve blood sugar management and aid in weight loss, offering a dual benefit that addresses common challenges faced by those with Type 2 diabetes.

What is the effectiveness track record for tirzepatide in treating type 2 diabetes?

Research shows that tirzepatide effectively treats type 2 diabetes. Studies have found that it significantly lowers blood sugar levels and aids in weight loss. One study noted that people who switched to tirzepatide had better blood sugar control after 12 weeks. Additionally, tirzepatide is linked to a lower risk of major heart and kidney problems. Importantly, it has already proven effective for type 2 diabetes, making it a reliable option for managing this condition. ^{6 7 8 9 10}

Who Is on the 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

Are You a Good Fit for This Trial?

Inclusion Criteria

No treatment with oral antidiabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, sodium-glucose linked transporter-2 inhibitor (SGLT-2i), thiazolidinediones, or α-glucosidase inhibitors.

Have Type 2 diabetes (T2D)

Have an HbA1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol)

Exclusion Criteria

BMI 25 or higher

BMI 25 or higher

Currently on stable dose of Ozempic, Trulicity or Victoza

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5 mg tirzepatide subcutaneously administered once weekly

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

How Is the Trial Designed?

Group I: 5 milligrams (mg) Tirzepatide Experimental Treatment 1 Intervention

Participants received 5 mg tirzepatide subcutaneously administered once weekly for 12 weeks.

Tirzepatide is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Mounjaro for:

• Type 2 diabetes

Approved in European Union as Mounjaro for:

• Type 2 diabetes

Approved in Canada as Mounjaro for:

• Type 2 diabetes

Approved in United States as Zepbound for:

• Weight loss
• Moderate to severe obstructive sleep apnea

Approved in United Kingdom as Zepbound for:

• Weight loss

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

Tirzepatide, approved in 2022, is a novel treatment for type 2 diabetes that acts on both GLP-1 and GIP pathways, showing significant efficacy in lowering blood sugar levels and promoting weight loss in various patient groups.

Clinical trials, including the SURPASS and SURMOUNT studies, indicate that tirzepatide has a safety profile similar to traditional GLP-1 receptor agonists, with common gastrointestinal side effects, making it a promising option for patients needing better glycemic and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. Krauss, Z., Hintz, A., Fisk, R.[2023]

Tirzepatide, a dual GIP and GLP-1 receptor agonist, has a safety profile similar to other GLP-1 receptor agonists, but higher doses (10mg and above) are associated with increased risks of hypoglycemia and treatment discontinuation.

In clinical trials involving 9818 patients, higher doses of tirzepatide led to more frequent gastrointestinal side effects like nausea, vomiting, and diarrhea, indicating that these adverse events are dose-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of tirzepatide-a new dual GLP1 and GIP agonist - is its safety profile acceptable? Meng, Z., Yang, M., Wen, H., et al.[2023]

LY3298176, a dual GIP and GLP-1 receptor agonist, demonstrated significant improvements in glycemic control and body weight reduction in both preclinical studies and a Phase 1b trial involving 142 subjects with type 2 diabetes mellitus (T2DM).

The most common side effects were mild to moderate gastrointestinal issues, which were dose-dependent, indicating that while LY3298176 is effective, monitoring for these side effects is important during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Coskun, T., Sloop, KW., Loghin, C., et al.[2021]

Tirzepatide demonstrated a dose-dependent ability to lower HbA1c levels in adults with type 2 diabetes, with reductions ranging from -17.71 to -22.35 mmol/mol compared to placebo, and was also more effective in reducing body weight than other treatments.

While tirzepatide did not increase the risk of hypoglycaemia compared to placebo and showed lower rates than basal insulin, it was associated with a higher incidence of gastrointestinal side effects, particularly nausea and vomiting, especially at the 15 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. Karagiannis, T., Avgerinos, I., Liakos, A., et al.[2023]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822209

Clinical Outcomes of Tirzepatide or GLP-1 Receptor ... Treatment with tirzepatide was associated with significantly lower hazards of all-cause mortality and major adverse cardiovascular and kidney events compared ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11320168/

Clinical Outcomes of Tirzepatide or GLP-1 Receptor Agonists ... Treatment with tirzepatide was associated with significantly lower hazards of all-cause mortality and major adverse cardiovascular and kidney events compared ...

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

Tirzepatide as Compared with Semaglutide for ... Clinically meaningful weight reductions occur with both medications, with reported mean weight reductions of up to 22.9% after nearly 3.5 years ...

4. uchicagomedicine.org uchicagomedicine.org/forefront/research-and-discoveries-articles/2024/may/research-on-glp-1-drugs

Research shows GLP-1 drugs are effective but complex GLP-1RA drugs came out on top, not only controlling blood glucose but also reducing the risk of major heart-related events and the risk of death ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1530891X24005159

Switching to Tirzepatide 5 mg From Glucagon-Like Peptide ... The improved glycemic levels at 12 weeks for people switching to tirzepatide 5 mg in this study trended similarly with results from prior clinical trials ...

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

Tirzepatide Once Weekly for the Treatment of Obesity Both efficacy and safety end points were analyzed with data from all randomly assigned participants (intention-to-treat population). Two ...

7. zepbound.lilly.com zepbound.lilly.com/hcp/clinical-data-weight

Clinical Data, Safety & Study Design | WR - Zepbound - Eli Lilly Learn more about Zepbound's® (tirzepatide) weight reduction (WR) efficacy and safety clinical data in adults with obesity and excess weight.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469573/

Real-World Safety Concerns of Tirzepatide ... receptor agonist, is approved for type 2 diabetes and weight management. Despite its efficacy, real-world safety data remain limited. This ...

9. fda.gov fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

FDA's Concerns with Unapproved GLP-1 Drugs Used for ... FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In ...

10. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK585056/

Tirzepatide - StatPearls - NCBI Bookshelf Tirzepatide is a novel medication approved by the US Food and Drug Administration (FDA) for treating type 2 diabetes mellitus (T2DM).