Sleeve Gastrectomy + Tirzepatide for Obesity

Overseen By Research Administrator

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Nicholas Skertich

Must not be taking: GLP-1 agonists

Disqualifiers: Pancreatitis, Thyroid cancer, Stroke, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding tirzepatide (a GIP/GLP-1 receptor agonist) after sleeve gastrectomy (a weight-loss surgery) aids in further weight loss and improves conditions such as Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea. The researchers aim to determine if this combination is more effective than surgery alone and whether it causes any additional side effects. Suitable candidates for this trial include those planning to undergo sleeve gastrectomy with either a BMI over 40 or a BMI over 35 accompanied by conditions like Type 2 diabetes or high blood pressure. As an Early Phase 1 trial, this research focuses on understanding how tirzepatide works in people, offering participants a chance to be among the first to explore its potential benefits.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using a GLP-1 agonist, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tirzepatide is generally safe for weight loss. In one study, participants with obesity who took tirzepatide lost about 18% of their body weight, even without diabetes. This finding suggests the drug can aid weight loss independently.

Common side effects included nausea, diarrhea, and constipation, but these were usually mild and short-lived. When combined with sleeve gastrectomy, tirzepatide might enhance weight loss and improve conditions like Type 2 diabetes and high blood pressure.

This trial is in an early phase, meaning the treatment is still undergoing safety testing. However, tirzepatide is already approved for other uses, such as managing diabetes, providing some understanding of its safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the treatment combination of sleeve gastrectomy and tirzepatide for obesity because it introduces a novel approach by combining surgery with a new medication. Unlike standard weight-loss surgeries, which typically rely solely on the mechanical reduction of stomach size, tirzepatide adds a pharmaceutical angle by mimicking hormones that help regulate appetite and blood sugar. This dual-action strategy could enhance weight loss and improve metabolic health more effectively than surgery alone. Additionally, tirzepatide is delivered via weekly injections, offering a manageable and consistent dosing schedule. This innovative combination has the potential to offer more comprehensive benefits for individuals struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that tirzepatide is effective for weight loss. In a 72-week study, participants taking tirzepatide lost a significant amount of weight, and the results persisted. In this trial, one group of participants will undergo sleeve gastrectomy and receive tirzepatide, while another group will undergo sleeve gastrectomy alone. Although weight loss surgery typically results in more weight loss than medications like tirzepatide, combining both might enhance outcomes. Tirzepatide may also help manage conditions such as Type 2 diabetes, high blood pressure, and high cholesterol. Overall, the drug appears promising for managing weight and related health issues. ^{2 3 6 7 8}

Who Is on the Research Team?

Nicholas Skertich, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with obesity, possibly having conditions like Type 2 diabetes, high blood pressure, cholesterol issues, or sleep apnea. Participants should not have had previous weight loss surgery and must be suitable candidates for sleeve gastrectomy.

Inclusion Criteria

I am scheduled for a sleeve gastrectomy as my first weight loss surgery.

My BMI is over 35 with diabetes, high blood pressure, high cholesterol, or sleep apnea, or it's over 40 regardless of these conditions.

Exclusion Criteria

I have had a heart attack or acute coronary syndrome.

Pregnancy/lactation

I have had a stroke in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo sleeve gastrectomy surgery

1 week

1 visit (in-person)

Treatment

Participants in the experimental group receive tirzepatide with a 4-week dose escalation period, followed by weekly doses starting at 6 months post-surgery

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of Type 2 Diabetes, High Cholesterol, and Sleep Apnea

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview

The study is testing if tirzepatide (Mounjaro), a medication aiding in weight loss when added after sleeve gastrectomy surgery, can enhance weight reduction and improve related health conditions more effectively than surgery alone.

How Is the Trial Designed?

Group I: SG-T: sleeve gastrectomy with tirzepatide Experimental Treatment 2 Interventions

In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months after surgery they will receive weekly 2.5mg doses (for 4 weeks). Afterwards, they will receive weekly 5mg doses. They will maintain this dose until 12 months after surgery.

Group II: SG-A: sleeve gastrectomy alone Active Control 1 Intervention

In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.

Who Is Running the Clinical Trial?

Nicholas Skertich

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

Tirzepatide (Mounjaro™) is a new treatment for type 2 diabetes that acts on both GIP and GLP-1 receptors, showing strong results in lowering blood glucose and promoting weight loss based on evidence from five SURPASS clinical trials.

The safety profile of tirzepatide is similar to that of existing GLP-1 receptor agonists, making it a promising option for early intervention in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug: Tirzepatide (Mounjaro&#8482;). Gettman, L.[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 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]

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]

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 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, 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 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 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]

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, 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 GLP-1/GIP receptor co-agonist, has been shown to significantly reduce glycosylated hemoglobin levels (1.87% to 3.02%) and body weight (5.4 to 12.9 kg) in people with type 2 diabetes over treatment periods of up to 104 weeks, demonstrating its efficacy compared to placebo and other diabetes medications.

In individuals without diabetes, tirzepatide also led to substantial weight loss (16.5% to 22.4%) over 72 weeks, indicating its potential for obesity management as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management. Sinha, R., Papamargaritis, D., Sargeant, JA., et al.[2023]

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In clinical trials, liraglutide showed a placebo-corrected weight loss of around 5 %, semaglutide 12 %, and tirzepatide 18 %. Common side ...