Tirzepatide for Obesity

(GLOW Trial)

Overseen By Charlotte Crotts, CCBDT

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: Wake Forest University Health Sciences

Must not be taking: Growth hormones, Weight management, Diabetes medications, Oral steroids

Disqualifiers: Cognitive impairment, Depression, Alcohol use, Diabetes, Heart disease, 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

Compensation: Varies

Number of Visits: 4

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how tirzepatide can improve health in older adults with obesity. The focus is on its effects on body structure, bone health, and physical activity over nine months. Participants must have a BMI between 30-37, or 27-30 with another weight-related health issue, and be able to attend regular study visits and meetings. This trial offers an opportunity to explore a new approach to weight management and overall health improvement. As a Phase 4 trial, it involves an FDA-approved treatment, aiming to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those regularly using certain diabetes medications, weight management drugs, and oral steroids. It's best to discuss your specific medications with the study team.

What is the safety track record for this treatment?

In a previous study, tirzepatide helped people with obesity lose weight, though some experienced side effects. The most common issues included stomach problems such as nausea, diarrhea, and vomiting. These side effects are typical for this type of medication and usually improve over time.

Real-world information on tirzepatide remains limited, but no major issues have emerged so far. Since this trial is in a later phase, the treatment has already demonstrated general safety. However, participants should always monitor their body's responses and report any concerns during the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tirzepatide is unique because it combines two different hormone actions, GLP-1 and GIP, into one medication. Most treatments for obesity, like semaglutide and liraglutide, primarily target just the GLP-1 receptor to help manage weight. But tirzepatide also targets the GIP receptor, which may enhance its ability to regulate appetite and glucose levels. Researchers are excited about tirzepatide because this dual-action approach could lead to more significant weight loss and improved metabolic health compared to current options. Additionally, it is administered via a simple once-weekly injection, which could make it more convenient for patients.

What is the effectiveness track record for tirzepatide in treating obesity?

Research has shown that tirzepatide, the treatment under study in this trial, aids in weight loss. One study found it more effective than semaglutide, resulting in about 6.5% more weight loss. Another study discovered that many participants on tirzepatide lost at least 10% of their starting weight. Additionally, a real-world study demonstrated that after six months, individuals using tirzepatide lost an average of 12.9% of their weight. These findings suggest that tirzepatide can significantly assist with weight loss, which is crucial for managing obesity and related health issues. ^{1 6 7 8 9}

Who Is on the Research Team?

Denise Houston, PhD

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

This trial is for older adults with obesity. Participants must be willing to take tirzepatide weekly, attend regular clinic visits and virtual meetings, use a smart scale daily, record their food and beverage intake, and monitor steps with an activity tracker.

Inclusion Criteria

Community dwelling

I can arrange my own travel for study visits.

Willing to provide informed consent

Exclusion Criteria

Vegan or other severe dietary restriction

My liver is not functioning properly or I have liver disease.

History of mild cognitive impairment or dementia or cognitive impairment on Montreal Cognitive Assessment (MoCA score <22)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide injections weekly and participate in counseling sessions on diet and physical activity over a 9-month period

9 months

Clinic visits every 4 weeks, group intervention sessions twice a month via video conference

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 tests the effects of tirzepatide on body composition, bone health, and physical performance over nine months. It involves frequent check-ins with healthcare professionals and group sessions via video conference.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 1 Intervention

Tirzepatide injection once weekly for 9 months

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

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]

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, 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]

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 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 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.

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 ...

2.

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 ...

3.

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, ...

4.

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 ...

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.

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 ...

7.

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 ...

8.

fda.gov

fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

FDA's Concerns with Unapproved GLP-1 Drugs Used for ...

FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In ...

9.

dom-pubs.onlinelibrary.wiley.com

dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16549

Tirzepatide and cardiometabolic parameters in obesity ...

7 SUMMARY OF SAFETY DATA THUS FAR ... Tirzepatide use is associated with gastrointestinal symptoms, most commonly nausea, diarrhoea, vomiting, ...