Strategies to Prevent Weight Regain for Obesity

Recruiting in Palo Alto (17 mi)

Overseen by Kelseanna Hollis-Hansen, PhD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas Southwestern Medical Center

Must be taking: GLP-1s

Disqualifiers: Psychiatric illness, Substance misuse, others

Trial Summary

What is the purpose of this trial?

This trial tests if special meals or a weight management app can help adults keep off weight after stopping a weight-loss medication. The study focuses on those who have lost significant weight and stopped the medication. The meals make healthy eating easier, and the app provides support for maintaining good habits.

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 focuses on people who have recently stopped taking GLP-1 receptor agonist medications. It seems likely that you should have already stopped taking GLP-1s to participate.

What data supports the effectiveness of the drug GLP-1 Receptor Agonist for preventing weight regain in obesity?

Research shows that GLP-1 receptor agonists, like semaglutide, can lead to significant weight loss in people with obesity, with studies indicating up to 15% weight loss. These drugs are also effective in managing weight in patients with type 2 diabetes, suggesting their potential in preventing weight regain. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

GLP-1 receptor agonists, like semaglutide and efpeglenatide, have been studied for weight management and may cause side effects such as increased heart rate. Concerns about their safety have been raised, but they are generally used in clinical settings with monitoring. ^{1 5 6 7 8}

How is the drug GLP-1 Receptor Agonist unique in preventing weight regain for obesity?

GLP-1 Receptor Agonists, like semaglutide, are unique because they help prevent weight regain by maintaining levels of free leptin, a hormone that regulates appetite, and are effective in promoting weight loss and improving heart health. Unlike some other treatments, they are administered as injections and are known for their high compliance rates and effectiveness in treating obesity. ^{1 4 9 10 11}

Research Team

Kelseanna Hollis-Hansen, PhD, MPH

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for adults who've lost over 10% of their body weight using GLP-1 receptor agonist medications, have stopped taking these meds within the last month, can consent to participate, and are fluent in English. It's not specified who cannot join.

Inclusion Criteria

I am 18 years old or older.

I have lost more than 10% of my weight using a GLP-1 receptor agonist.

I stopped taking GLP-1 receptor agonist less than 30 days ago.

Exclusion Criteria

Major psychiatric illness or substance misuse that could impair ability to participate

Participation in a study or program involving medically tailored meals or Noom® within the past 12-months

I can eat solid foods and have no conditions that cause weight loss.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either medically tailored meals, a Noom® subscription, or usual care for four months after GLP-1 Receptor Agonist cessation

16 weeks

Follow-up

Participants are monitored for adherence, satisfaction, and weight maintenance after the intervention

4 weeks

Treatment Details

Interventions

• GLP-1 Receptor Agonist (GLP-1 Receptor Agonist)
• Medically tailored meals (Procedure)
• Noom® (Behavioural Intervention)

Trial Overview The study explores if usual care, medically tailored meals or a digital health program called Noom® can help maintain weight loss after stopping obesity medication (GLP-1s). The goal is to find cost-effective ways to keep the weight off long-term.

Participant Groups

Group I: Noom® Experimental Treatment 2 Interventions

Participants will receive a paid Noom® subscription for four-months. Noom® is a subscription-based mobile application that provides food intake and exercise tracking and uses principles from psychology to motivate behavior change.

Group II: Medically tailored meals Experimental Treatment 2 Interventions

Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months.

Group III: Usual care Placebo Group 1 Intervention

Participants will receive usual care from their provider.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Daniel K. Podolsky

University of Texas Southwestern Medical Center

Chief Executive Officer since 2008

MD from Harvard Medical School

Robert L. Bass

University of Texas Southwestern Medical Center

Chief Medical Officer since 2019

MD from University of Texas Southwestern Medical School

UT Southwestern Nutrition Obesity Research Center

Collaborator

Trials

1

Recruited

60+

Findings from Research

Chronic administration of the GLP-1 receptor agonist semaglutide (SEMA) in rats led to reduced food intake and body weight, indicating its efficacy in weight management, similar to effects seen in humans with obesity.

Interestingly, while SEMA-treated rats consumed more sucrose at lower concentrations compared to controls, their overall energy intake became similar to that of control rats, suggesting that SEMA's impact on food intake may vary depending on the type of caloric source available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Semaglutide Treatment in Rats Leads to Daily Excessive Concentration-Dependent Sucrose Intake. Cawthon, CR., Blonde, GD., Nisi, AV., et al.[2023]

GLP-1 receptor agonists, such as exenatide and liraglutide, resulted in significant weight loss in overweight or obese patients, with an average loss of 2.9 kg compared to control groups, based on a systematic review of 25 trials involving 6411 participants.

These medications not only aided in weight loss but also improved blood pressure and cholesterol levels without causing hypoglycemia, although they were associated with some gastrointestinal side effects like nausea and diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. Vilsbøll, T., Christensen, M., Junker, AE., et al.[2022]

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are effective for weight loss in overweight or obese patients with type 2 diabetes, showing significant reductions in weight compared to placebo across multiple studies involving 27 trials.

There was no significant difference in weight loss efficacy among the different GLP-1 RAs tested, indicating that they are similarly effective options for managing weight in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Glucagon-Like Peptide 1 Receptor Agonists on Weight Loss in Type 2 Diabetes: A Systematic Review and Mixed Treatment Comparison Meta-Analysis. Potts, JE., Gray, LJ., Brady, EM., et al.[2022]

GLP-1 receptor agonists are effective for treating type 2 diabetes and obesity, showing significant improvements in blood sugar control and weight loss, but they still fall short compared to the results of bariatric surgery.

Emerging co-agonist therapies, such as tirzepatide and combinations with amylin, show promise for enhanced efficacy, suggesting that future treatments could outperform current GLP-1R agonists in managing metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 receptor co-agonists for treating metabolic disease. Baggio, LL., Drucker, DJ.[2021]

GLP-1 receptor agonists, like liraglutide (Saxenda), have been shown to effectively promote weight loss in both patients with and without type 2 diabetes, making them a valuable option for long-term weight management.

These medications work by enhancing feelings of fullness and slowing down gastric emptying, and they generally have a favorable safety profile, with mild gastrointestinal symptoms being the most common side effects reported in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of glucagon-like peptide 1 receptor agonists in management of obesity. Isaacs, D., Prasad-Reddy, L., Srivastava, SB.[2022]

In a study involving 10 healthy overweight males, the GLP-1 receptor agonist exenatide was found to increase heart rate by an average of 6.8 beats per minute and systolic blood pressure by 9.8 mmHg, indicating a significant cardiovascular effect.

The increase in heart rate and blood pressure was linked to sympathetic nervous system activation rather than a reflex response to vasodilation, suggesting that the mechanism behind these changes is related to increased sympathetic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exenatide acutely increases heart rate in parallel with augmented sympathetic nervous system activation in healthy overweight males. Smits, MM., Muskiet, MH., Tonneijck, L., et al.[2022]

In a study of 52 healthy obese individuals, the GLP-1 receptor agonist liraglutide helped maintain a 12% weight loss over 52 weeks by significantly reducing the increase in soluble leptin receptors and preserving free leptin levels, which are important for appetite regulation.

Participants receiving liraglutide experienced greater weight maintenance and improved glucose tolerance compared to the control group, suggesting that GLP-1RAs can effectively support weight loss maintenance and potentially prevent pre-diabetes in obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment with a GLP-1 receptor agonist diminishes the decrease in free plasma leptin during maintenance of weight loss. Iepsen, EW., Lundgren, J., Dirksen, C., et al.[2022]

In a study of 44 non-diabetic patients who experienced weight regain or insufficient weight loss after bariatric surgery, adjunct treatment with the GLP-1 receptor agonist semaglutide resulted in significant weight loss of -6.0% after 3 months and -10.3% after 6 months, indicating its efficacy in managing post-bariatric weight issues.

The study suggests that semaglutide could be a beneficial treatment option for patients struggling with weight regain after surgery, but further research through prospective randomized controlled trials is needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of Semaglutide Once-Weekly in Patients Without Type 2 Diabetes with Weight Regain or Insufficient Weight Loss After Bariatric Surgery-a Retrospective Analysis. Lautenbach, A., Wernecke, M., Huber, TB., et al.[2022]

References

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

Chronic Semaglutide Treatment in Rats Leads to Daily Excessive Concentration-Dependent Sucrose Intake. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. [2022]

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

The Effect of Glucagon-Like Peptide 1 Receptor Agonists on Weight Loss in Type 2 Diabetes: A Systematic Review and Mixed Treatment Comparison Meta-Analysis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 receptor co-agonists for treating metabolic disease. [2021]

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

Role of glucagon-like peptide 1 receptor agonists in management of obesity. [2022]

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

Body weight management and safety with efpeglenatide in adults without diabetes: A phase II randomized study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Potential side effects to GLP-1 agonists: understanding their safety and tolerability. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Exenatide acutely increases heart rate in parallel with augmented sympathetic nervous system activation in healthy overweight males. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Treatment with a GLP-1 receptor agonist diminishes the decrease in free plasma leptin during maintenance of weight loss. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

GLP-1 receptor agonists for the treatment of obesity: Role as a promising approach. [2023]

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

The Potential of Semaglutide Once-Weekly in Patients Without Type 2 Diabetes with Weight Regain or Insufficient Weight Loss After Bariatric Surgery-a Retrospective Analysis. [2022]