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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called tirzepatide to assess its effects on the liver in people with MASLD, a condition often associated with obesity or type 2 diabetes. Participants will take the medication for 12 months and undergo regular check-ups, including blood tests and liver ultrasounds. This trial may suit individuals diagnosed with MASLD who also have obesity or type 2 diabetes, along with related health issues like high blood pressure or high cholesterol. As an Early Phase 1 trial, the research aims to understand how tirzepatide works in people, offering participants the opportunity to be among the first to receive this treatment.

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.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide is generally well-tolerated. In a study involving adults with obesity, tirzepatide led to significant weight loss, demonstrating its effectiveness. However, researchers are still gathering safety information, particularly regarding everyday use. Some reports mention side effects, but they do not clearly indicate their frequency or severity.

Since tirzepatide is already used for type 2 diabetes and obesity, there is some understanding of its safety. Most users have tolerated it well, but further research is needed to fully understand potential risks, especially for new uses like treating MASLD, a liver disease. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tirzepatide is unique because it combines the actions of two hormones, GLP-1 and GIP, to help control appetite and blood sugar levels, which is different from most current obesity treatments that mainly target only one hormone. This dual-action approach could make it more effective at reducing weight. Researchers are excited because tirzepatide has shown promising results in earlier studies, potentially offering better weight loss outcomes compared to existing options like diet, exercise, and medications solely targeting GLP-1.

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

Research has shown that tirzepatide can aid in weight loss, which is crucial for addressing health issues related to obesity. In one study, participants taking tirzepatide lost more than 10% of their body weight, with some losing even more. Another study found that continued use of tirzepatide helped maintain weight loss, while discontinuation led to weight regain. Weight loss is important as it can improve or prevent health problems linked to obesity, such as type 2 diabetes and high cholesterol. These findings suggest that tirzepatide might also benefit individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), a condition related to obesity. Participants in this trial will receive tirzepatide for 12 months to evaluate its effectiveness in weight loss and related health improvements. ^{2 4 6 7 8}

Who Is on the Research Team?

Eliseo Castillo

Principal Investigator

UNM Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2812936

Continued Treatment With Tirzepatide for Maintenance of ... From randomization (at week 36), those switched to placebo experienced a 14% weight regain and those continuing tirzepatide experienced an ...

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

Tirzepatide Once Weekly for the Treatment of Obesity At week 72, more participants in the tirzepatide groups had reductions in body weight of 10% or more, 15% or more, and 20% or more from baseline ...

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

Tirzepatide as Compared with Semaglutide for ... Tirzepatide was superior to semaglutide with respect to weight reduction (estimated treatment difference, −6.5 percentage points; 95% CI, −8.1 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12326891/

Weight reduction over time in tirzepatide‐treated ... A weight reduction of 5% or more is typically needed to improve or prevent some of the complications of obesity, such as type 2 diabetes, dyslipidaemia, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S126236362500031X

Real-world use and effectiveness of tirzepatide among ... In the current study, individuals who persisted on tirzepatide for 6 months experienced mean weight reduction of 12.9 % at 6 months post-index, although most ...

6. nature.com nature.com/articles/s41591-025-03978-z

A systematic review and meta-analysis of the efficacy and ... Tirzepatide was associated with a greater reduction of total body fat mass and a significantly lower reduction in total fat-free mass; similar ...

7. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1593134/full

Efficacy and safety of tirzepatide for weight loss in patients ... This meta-analysis aims to evaluate efficacy and safety of tirzepatide for weight loss, including its dose-response relationship and adverse event profile.

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

Real-World Safety Concerns of Tirzepatide Despite its efficacy, real-world safety data remain limited. This study analyzed post-marketing adverse events (AEs) associated with tirzepatide ...