Tirzepatide for Obesity

Overseen By Varun Jain, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Marlene Starr

Must not be taking: GLP-1 agonists, Immunosuppressants

Disqualifiers: Thyroid carcinoma, Pancreatitis, Diabetes, 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: 7

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking tirzepatide, a medication for obesity, before bariatric surgery can reduce inflammation and improve outcomes such as weight loss and overall health post-surgery. Researchers aim to determine if this pre-surgery treatment enhances control of blood sugar, blood pressure, and cholesterol, and reduces complications within 30 days after surgery. Participants will either receive tirzepatide or not, allowing for a comparison of outcomes between the two groups. This trial suits adults already enrolled in a weight loss surgery program, with a BMI of 40 or more and at least one obesity-related health issue. As a Phase 4 trial, the study focuses on understanding how this FDA-approved and effective treatment can benefit 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, if you are currently using a GLP-1 or GLP-1/GIP receptor agonist, or have used one in the past 90 days, you cannot participate in the trial.

What is the safety track record for tirzepatide?

Research has shown that tirzepatide is generally safe for people. Studies have found it aids in weight loss and managing Type 2 diabetes. Some individuals taking tirzepatide experience stomach-related side effects such as nausea, vomiting, and diarrhea. These side effects are common but typically mild and temporary. Serious side effects are rare. Overall, tirzepatide has been safely used for other conditions, supporting its safety profile. ^{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, which are involved in regulating appetite and insulin levels. Most treatments for obesity, like lifestyle changes and medications such as orlistat or phentermine, either curb appetite or block fat absorption. Tirzepatide, on the other hand, offers a dual-action approach by enhancing both insulin sensitivity and reducing hunger, potentially leading to more effective weight loss. Researchers are excited about its potential to offer better results with fewer side effects compared to current options.

What evidence suggests that tirzepatide might be an effective treatment for obesity?

Research has shown that tirzepatide helps people with obesity lose weight. In studies, participants taking tirzepatide lost significant weight, with some losing more than 20% of their body weight. This trial will compare the effects of standard care alone with standard care plus tirzepatide. The treatment also improves health by controlling blood sugar and lowering the risk of heart and kidney issues. While most people tolerate tirzepatide well, some might experience side effects like stomach problems. This treatment is already used for obesity, demonstrating its effectiveness and safety for many patients. ^{1 3 4 6 7}

Who Is on the Research Team?

Simon J Fisher, MD. PhD

Principal Investigator

University of Kentucky

Philip A Kern, MD

Principal Investigator

University of Kentucky

Barbara Nikolajczyk, PhD

Principal Investigator

University of Kentucky

Marlene Starr, PhD

Principal Investigator

University of Kentucky

Varun Jain, MD

Principal Investigator

University of Kentucky

William B Inabnet, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals with obesity, especially those planning to undergo bariatric surgery. Participants should be willing to take a drug called tirzepatide or follow standard care for three months before their surgery and keep a diary of their experience.

Inclusion Criteria

Demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing

Enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)

My BMI is 45 or higher and I have at least one obesity-related health issue.

Exclusion Criteria

I or my family have a history of medullary thyroid cancer.

I have active gallstones or jaundice that hasn't been treated.

I am currently using, or have used in the last 90 days, a GLP-1 medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive tirzepatide or no treatment once a week for 3 months before surgery

12 weeks

3 visits (in-person, monthly)

Surgery

Participants undergo planned bariatric surgery

1 day

Follow-up

Participants are monitored for safety and effectiveness after surgery, with assessments at 1, 3, 6, and 12 months post-surgery

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview

The study tests if taking tirzepatide before bariatric surgery can reduce inflammation and improve weight loss and health outcomes post-surgery compared to not taking the drug. Patients will visit the clinic monthly for checkups.

How Is the Trial Designed?

Group I: Standard of Care plus Drug Experimental Treatment 1 Intervention

Participant receives drug for 3 months prior to surgery

Group II: Standard of Care Alone Active Control 1 Intervention

Who Is Running the Clinical Trial?

Marlene Starr

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

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]

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 systematic review of randomized controlled trials involving 5800 patients, tirzepatide was found to be highly effective for weight loss, with 78.22% achieving at least 5% weight loss and 32.28% achieving at least 15% weight loss.

Tirzepatide demonstrated superior weight loss compared to placebo and semaglutide, with a significant mean weight loss of -12.47 kg at the 5 mg dose, while showing a manageable safety profile with only a slight increase in gastrointestinal adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Tan, B., Pan, XH., Chew, HSJ., 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 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 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]

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 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]

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, 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 is a novel medication that acts on both GIP and GLP-1 receptors, enhancing insulin secretion and reducing glucagon levels, which helps improve glycemic control in adults with type 2 diabetes mellitus (T2DM).

It received its first approval in the USA in May 2022 for T2DM treatment and is currently being studied for additional conditions like obesity, heart failure, and non-alcoholic steatohepatitis, indicating its potential for broader therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: First Approval. Syed, YY.[2022]

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]

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