Tirzepatide for Obesity

Overseen By Kristen Gonzales, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of New Mexico

Must be taking: Tirzepatide

Must not be taking: Other GLP1 RAs

Disqualifiers: Pregnancy, Alcohol abuse, Cancer, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 months

8 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use other anti-obesity medications or GLP1 RAs (a type of diabetes medication) within 3 months of joining the study.

What data supports the effectiveness of the drug Tirzepatide for obesity?

Research shows that Tirzepatide, when added to lifestyle changes, helps people with obesity lose more weight over 72 weeks. This drug has been effective in both people with and without type 2 diabetes, making it a promising option for weight management. ^{1 2 3 4 5}

Is tirzepatide safe for humans?

Tirzepatide has been studied for its safety in people with obesity and type 2 diabetes, showing a safety profile similar to other drugs in its class, with common side effects like mild to moderate stomach issues such as nausea and diarrhea. It has been approved for use in treating type 2 diabetes in several regions, indicating it is generally considered safe for human use. ^{2 3 4 6 7}

How is the drug Tirzepatide unique for treating obesity?

Tirzepatide is unique because it combines two actions in one drug: it mimics hormones that help control blood sugar and appetite, making it effective for weight loss. Unlike other treatments, it is taken once a week, which can be more convenient for patients. ^{1 2 3 4 8}

What is the purpose of this trial?

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is the most common cause of chronic liver disease worldwide and predominately affects individuals with overweight and obesity, as well as those with type 2 diabetes and cardiovascular disease. Tirzepatide is a medication used to treat type 2 diabetes and obesity. It has also been shown to help with MASLD. The purpose of this study is to study how tirzepatide affects the liver in patients with MASLD. Participants will be asked to: * Take tirzepatide for 12 months. * Come in for clinic visits every 3 months. * Have blood drawn at baseline, 6, and 12 months. * Complete a liver ultrasound at baseline and at 12 months.

Research Team

Eliseo Castillo

Principal Investigator

UNM Cancer Center

Eligibility Criteria

This trial is for individuals with obesity who may also have MASLD, a common liver condition linked to being overweight. Participants will use tirzepatide for one year and must be willing to visit the clinic every three months and undergo blood tests and liver ultrasounds at specified times.

Inclusion Criteria

Evidence of steatotic liver disease

English speaking

I am diagnosed with MASLD based on heart and metabolic health measures.

Exclusion Criteria

Pregnancy or breast feeding

Reports alcohol intake exceeding specified limits or high AUDIT score

Other identifiable causes of steatosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take tirzepatide for 12 months with clinic visits every 3 months

12 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tirzepatide

Trial Overview The study is testing the effects of tirzepatide on patients with obesity-related MASLD. It aims to understand how this medication, already used for type 2 diabetes and weight management, influences liver health over a period of 12 months.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

Individuals in the intervention arm (only arm) will receive tirzepatide for 12 months.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

University of New Mexico Cancer Center

Collaborator

Trials

7

Recruited

160+

Findings from Research

Tirzepatide, administered once weekly, has been shown to be effective in promoting weight loss in individuals with obesity, as demonstrated in a clinical study.

The treatment not only aids in weight reduction but also improves metabolic health markers, making it a promising option for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In adults with obesity without diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. Davidson, MB.[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]

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]

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 &#8805;27 kg/m2 and type 2 diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. Davidson, MB.[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 new GLP-1 receptor agonist, was found to be more effective for weight loss compared to other GLP-1RAs like semaglutide and liraglutide, with significant weight loss observed in over 12,300 patients in the analysis.

While all GLP-1RAs were associated with gastrointestinal side effects, tirzepatide showed better efficacy outcomes for weight loss while maintaining a similar safety profile to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of glucagon-like peptide-1 receptor agonists for the management of obesity in adults without diabetes: A network meta-analysis of randomized clinical trials. Alkhezi, OS., Alahmed, AA., Alfayez, OM., et al.[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]

In a phase 3b clinical trial involving 1428 adults with type 2 diabetes, tirzepatide significantly reduced HbA1c levels more than prandial insulin lispro after 52 weeks, achieving a mean HbA1c of 6.7% compared to 7.7% for insulin lispro.

Tirzepatide also led to greater weight loss (-9.0 kg) compared to insulin lispro (-3.2 kg) and had a much lower rate of hypoglycemia events, making it a safer option for patients inadequately controlled on basal insulin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial. Rosenstock, J., Frías, JP., Rodbard, HW., et al.[2023]

References

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

In adults with obesity without diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. [2022]

2. England 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. [2023]

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

Tirzepatide Once Weekly for the Treatment of Obesity. [2023]

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

In adults with BMI &#8805;27 kg/m2 and type 2 diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of glucagon-like peptide-1 receptor agonists for the management of obesity in adults without diabetes: A network meta-analysis of randomized clinical trials. [2023]

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

Efficacy and Safety of Tirzepatide in Adults With Type 2 Diabetes: A Perspective for Primary Care Providers. [2023]

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

Tirzepatide vs Insulin Lispro Added to Basal Insulin in Type 2 Diabetes: The SURPASS-6 Randomized Clinical Trial. [2023]