Semaglutide + Liraglutide for Obesity

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must be taking: GLP-1 medications

Must not be taking: Insulin, Secretagogues

Disqualifiers: Pregnancy, Gastrointestinal disorders, Renal impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how stopping GLP-1 medications, such as liraglutide or semaglutide, affects gastric emptying. It targets individuals already using these medications to manage obesity. Participants will either continue their current treatment or switch to a different form, such as oral or injectable semaglutide. Suitable candidates have maintained a stable dose of these medications for at least five weeks. The trial excludes those with significant stomach issues or those unable to adjust their lifestyle during the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it does require that you are already on a maintenance treatment with certain GLP-1 medications like liraglutide or semaglutide. If you are taking other medications that affect stomach motility, you may need to stop those.

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

Research shows that both liraglutide and semaglutide are generally well-tolerated. Studies have found that a 3.0 mg dose of liraglutide is safe and effective for weight management. The most common side effects are mild, such as nausea, diarrhea, or constipation, and they typically improve over time.

For oral semaglutide, a 14 mg dose is considered safe for most individuals. Like liraglutide, it can cause stomach-related side effects such as nausea and vomiting, but these usually decrease as the body adjusts to the medication.

Injected semaglutide also has a good safety record. Research has shown it can reduce major heart-related events and aid in weight loss. Its side effects are similar to the oral form and include stomach issues.

Both treatments have FDA approval for other conditions, suggesting safety for new uses. However, this study is in an early phase, focusing on ensuring safety in humans. Participants' experiences will provide more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments for obesity involving semaglutide and liraglutide because of their unique delivery methods and potential effectiveness. Unlike many current treatments that focus mainly on appetite suppression or calorie absorption, semaglutide and liraglutide are glucagon-like peptide-1 (GLP-1) receptor agonists that help regulate blood sugar and reduce appetite. Liraglutide is administered once daily via a subcutaneous injection, while semaglutide offers flexibility with an oral daily option and a subcutaneous weekly injection. These varied delivery methods could provide more personalized treatment options and potentially enhance adherence and effectiveness in managing obesity.

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

This trial will compare the effectiveness of different treatments for obesity. Studies have shown that liraglutide, which participants in this trial may receive, effectively aids weight loss. For example, users of liraglutide have lost about 5.4% to 6.0% of their body weight, improving overall health. Research suggests that oral semaglutide, another treatment option in this trial, is also promising, with about one-third of users losing more than 10% of their body weight. Additionally, semaglutide taken by injection, also tested in this trial, helped people lose an average of 15.7 kg (around 35 pounds) more than those who did not take it. These treatments are considered effective for managing obesity and improving related health conditions. ^{2 6 7 8 9}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for individuals with obesity who are currently using GLP-1 medications like liraglutide or semaglutide, either injected or taken by mouth. The study will look at how fasting and pausing their medication affects food remaining in the stomach.

Inclusion Criteria

I have been on specific diabetes medication for the required time before screening.

Exclusion Criteria

Unusual meal habits and special diet requirements or unwillingness to eat the meals provided in the study

Previous dosing in this study

Previous rescreening for this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLP-1 RA treatment (liraglutide, oral semaglutide, or s.c. semaglutide) and undergo fasting to measure gastric contents

3 weeks

Multiple visits for fasting and gastric content measurement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Liraglutide
• Semaglutide

Trial Overview The study examines the impact of different fasting durations and temporary discontinuation of GLP-1 drugs on gastric emptying in obese patients taking oral or injectable forms of semaglutide and injectable liraglutide.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 1 Intervention

Participants will receive semaglutide subcutaneously.

Group II: Oral semaglutide Experimental Treatment 2 Interventions

Participants will receive semaglutide orally.

Group III: Liraglutide Experimental Treatment 1 Intervention

Participants will receive liraglutide subcutaneously.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11508960/

Real-World Clinical Effectiveness of Liraglutide for Weight ... A weight loss of 5–10% has been shown to reduce obesity-related complications and improve quality of life. The efficacy and safety of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5358074/

Liraglutide for weight management: a critical review of ... - PMC Conclusion. Liraglutide has been shown to be effective at inducing and sustaining weight loss in a population of obese patients including those with ...

3. e-jcpp.org e-jcpp.org/journal/view.php?number=61

The effects and side effects of liraglutide as a treatment ... In a long-term clinical study, weight loss due to treatment with 0.3 mg of liraglutide was reported to be 5.4% to 6.0%, which was superior to ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823644

One-Year Weight Reduction With Semaglutide or ... Overall, 141 patients (37.4%) receiving semaglutide for obesity achieved 10% or greater body weight reduction vs 223 (16.6%) of those receiving ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1411892

A Randomized, Controlled Trial of 3.0 mg of Liraglutide in ... In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9325632/

Efficacy and Safety of Liraglutide 3.0 mg in Patients with ... Liraglutide in 3.0 mg subcutaneous dose demonstrated significant weight reduction with a reasonable safety profile for patients with overweight or obesity ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2667368124000299

Weight loss outcomes, tolerability, side effects, and risks GLP-1RAs demonstrated significant weight loss outcomes. In clinical trials, liraglutide showed a placebo-corrected weight loss of around 5 %, semaglutide 12 %, ...

8. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00599-6/fulltext

Safety and effects of anti-obesity medications on weight ... Outcomes related to liraglutide showed slightly lower quality due to high-bias risk in some studies. Notably, tirzepatide-related outcomes ...

9. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2807724

Safety and Efficacy of Liraglutide, 3.0 mg, Once Daily vs ... The results of this study demonstrate that liraglutide, 3.0 mg, was safe and effective as a weight management intervention in this patient population.