Tirzepatide for Type 2 Diabetes and Obesity

Recruiting in Palo Alto (17 mi)

+65 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Eli Lilly and Company

Must be taking: Metformin

Must not be taking: Weight loss drugs

Disqualifiers: Type 1 diabetes, Renal impairment, Cardiovascular conditions, others

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Will I have to stop taking my current medications?

The trial requires participants to continue taking metformin, as it is part of the study's criteria. However, if you are taking other medications, the protocol does not specify whether you need to stop them.

What data supports the effectiveness of the drug Tirzepatide for type 2 diabetes and obesity?

Tirzepatide has been shown to significantly reduce blood sugar levels and body weight in patients with type 2 diabetes, with some losing more than 10% of their initial weight. It was more effective than other treatments like semaglutide and insulin in clinical trials, and it also improved insulin sensitivity and reduced appetite. ^{1 2 3 4 5}

Is tirzepatide safe for humans?

Tirzepatide has been shown to be generally safe in humans, with common side effects including nausea, vomiting, diarrhea, and constipation, especially at higher doses. It has also been associated with a reduction in cardiovascular events, indicating cardiovascular safety. ^{1 2 3 4 6}

How is the drug Tirzepatide different from other treatments for type 2 diabetes and obesity?

Tirzepatide is unique because it is the first drug that acts as a dual agonist for both GIP and GLP-1 receptors, which helps improve blood sugar control and leads to significant weight loss. It is more effective in reducing blood sugar levels and body weight compared to other treatments like semaglutide, and it is administered once a week. ^{1 4 5 7 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 2 diabetes and obesity, specifically those with a BMI of 35 or higher who have maintained a stable weight and been on metformin treatment for at least 90 days. Participants should not have had significant weight changes recently.

Inclusion Criteria

Are you currently taking Metformin only to manage your diabetes?

Exclusion Criteria

Do you have a recent history of myocardial infarction, stroke, unstable angina, congestive heart failure, or coronary artery revascularization?

Have you recently used products intended for weight loss including prescription drugs, over the counter drugs or herbal preparations?

Have you ever had surgery for obesity, or do you plan to undergo surgery shortly?

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 5 weeks

Treatment

Participants receive tirzepatide or placebo subcutaneously, with primary endpoint at Week 44

44 weeks

Extension

Tirzepatide extension until Week 80

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tirzepatide (GLP-1 Receptor Agonist)

Trial Overview The study tests the safety and effectiveness of different doses of an experimental drug called Tirzepatide in people taking metformin for Type 2 diabetes and obesity over approximately 89 weeks. Some participants will receive Tirzepatide, while others will get a placebo.

Participant Groups

Group I: Tirzepatide High Dose 2 Experimental Treatment 1 Intervention

Participants will receive tirzepatide SC.

Group II: Tirzepatide High Dose 1 Experimental Treatment 1 Intervention

Participants will receive tirzepatide subcutaneously (SC).

Group III: Tirzepatide Active Control 1 Intervention

Participants will receive tirzepatide SC.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo.

Tirzepatide is already approved in Canada for the following indications:

Approved in Canada as Mounjaro for:

• Type 2 diabetes

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 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]

Tirzepatide, a medication for type 2 diabetes, shows a dose-dependent increase in gastrointestinal adverse events (AEs), with nausea and diarrhea being the most common, affecting up to 49% of participants at the highest dose (15 mg).

Despite the gastrointestinal side effects, serious adverse events like severe hypoglycemia and acute pancreatitis are rare (≤ 1%), indicating that tirzepatide is generally safe for use in patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Tirzepatide. Mishra, R., Raj, R., Elshimy, G., et al.[2023]

Tirzepatide, the first dual GIP/GLP-1 receptor co-agonist approved for type 2 diabetes, significantly reduces HbA1c levels (by 1.24 to 2.58%) and body weight (by 5.4-11.7 kg) in clinical trials involving type 2 diabetic patients, outperforming the selective GLP-1 RA semaglutide.

The safety profile of tirzepatide is similar to that of other GLP-1 receptor agonists, with common side effects including nausea and diarrhea, and it shows potential cardiovascular safety, as no significant increase in major adverse cardiovascular events was observed during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. Nauck, MA., D'Alessio, DA.[2022]

Tirzepatide significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.

While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review. Lin, F., Yu, B., Ling, B., et al.[2023]

Tirzepatide, a dual GIP and GLP-1 receptor agonist, showed significant reductions in Hemoglobin A1c levels (up to 3.02%) and weight loss in adults with uncontrolled type 2 diabetes, outperforming both placebo and active comparators like semaglutide.

The safety profile of tirzepatide was comparable to semaglutide regarding gastrointestinal adverse effects, and it did not increase the incidence of major cardiovascular events compared to insulin glargine, indicating it may be a valuable addition to diabetes treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2023]

Tirzepatide, a once-weekly medication for type 2 diabetes, not only improves blood sugar control but also leads to significant weight loss and positive changes in cardiovascular health, such as reduced blood pressure and improved insulin sensitivity.

The weight loss and metabolic benefits of tirzepatide are linked to its dual action as a GIP and GLP-1 receptor agonist, suggesting that these mechanisms play a crucial role in its effectiveness for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. Várkonyi, TT., Pósa, A., Pávó, N., et al.[2023]

Tirzepatide, a new medication approved by the FDA, acts as an agonist for both GLP-1 and GIP receptors, which helps improve blood sugar control in patients with type II diabetes when combined with diet and exercise.

This drug represents a significant advancement in diabetes management, offering a new approach to treatment by targeting multiple pathways involved in glucose regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. Al-Horani, RA., Chedid, M.[2023]

References

1. Germany 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. [2023]

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

Tirzepatide: Clinical review of the "twincretin" injectable. [2023]

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

Adverse Events Related to Tirzepatide. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. [2022]

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

Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]

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

Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. [2023]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Tirzepatide: A New Generation Therapeutic for Diabetes Type 2. [2023]