Semaglutide for Obesity

(STABLE Wt Loss Trial)

Recruiting at -1 trial locations

Overseen By Kaitlyn DeRouen, BA, BSEd

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Pennsylvania

Must not be taking: Weight loss drugs, Oral steroids

Disqualifiers: Diabetes, Severe depression, Substance abuse, 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: 168

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the effect of semaglutide on eating behavior, appetite (hunger/fullness), and food liking in the long-term, as compared to placebo. All participants will receive lifestyle modification (diet and exercise) counseling, and will be prescribed the FDA-approved weight loss medication, semaglutide, or placebo (an inactive saline solution) for 72 weeks.

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 does exclude those who have changed their chronic medication type or dosage in the past 3 months. It also excludes those who have used medications known to affect weight in the last 6 months.

What data supports the effectiveness of the drug Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY] for obesity?

Research shows that Semaglutide 2.4 mg, when taken once a week, helps people who are overweight or obese lose weight and improve their heart health. It has been effective in both people with and without diabetes. ^{1 2 3 4 5}

Is semaglutide safe for humans?

Semaglutide, used for weight management, is generally safe for humans, but it can cause gastrointestinal issues like nausea and diarrhea. These side effects are common but usually mild and tend to decrease over time. ^{2 4 6 7 8}

How is the drug semaglutide unique for treating obesity?

Semaglutide, marketed as Wegovy, is unique for obesity treatment because it is a once-a-week injection that mimics a hormone (GLP-1) to help control appetite and weight. Unlike other treatments, it was initially used for diabetes and later found effective for weight loss, making it a novel option for managing obesity. ^{2 3 4 5 9}

Eligibility Criteria

Adults aged 18-70 wanting to lose weight, with a BMI ≥ 30 or ≥ 27 with obesity-related health issues. Must not be pregnant, able to consent, and plan to stay in Philadelphia for the study duration. Excludes those with uncontrolled diabetes or hypertension, recent pancreatitis or cancer history, severe psychiatric disorders, recent weight loss drugs use, and certain cardiovascular conditions.

Inclusion Criteria

Plan to remain in the Philadelphia area for the next 1.5 years.

non-pregnant, evidenced by a negative urine pregnancy test

Eligible female patients will be: non-pregnant, evidenced by a negative urine pregnancy test

Exclusion Criteria

I was diagnosed with bulimia nervosa in the last 5 years.

I have not taken weight-altering or GLP-1 drugs in the last 6 months.

I have had acute pancreatitis in the past 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Study 1)

Participants receive semaglutide or placebo with lifestyle intervention for 60 weeks

60 weeks

Visits at baseline, weeks 20, 40, and 60

Re-randomized Medication Withdrawal (Study 2)

Semaglutide-treated subjects are re-randomized to semaglutide or placebo for 12 weeks

12 weeks

Final assessment at week 72

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Final safety visit at week 76

Treatment Details

Interventions

• Behavioral Treatment
• Placebo
• Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]

Trial Overview The trial tests if semaglutide affects appetite and eating habits over time compared to a placebo. Participants also receive lifestyle advice on diet and exercise. Semaglutide is an FDA-approved medication for weight loss administered subcutaneously for 72 weeks alongside behavioral treatment.

Participant Groups

Group I: Behavioral Treatment + Placebo Active Control 2 Interventions

Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo

Group II: Behavioral Treatment + Medication Active Control 2 Interventions

Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Novo Nordisk A/S

Industry 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

Findings from Research

In a meta-analysis of six randomized controlled trials involving 3962 overweight or obese individuals, subcutaneous semaglutide 2.4 mg administered weekly resulted in significant and sustainable weight loss, with an average reduction of 11.8% in body weight compared to placebo.

Semaglutide was well tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating a favorable safety profile for non-diabetic overweight or obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. Qin, W., Yang, J., Deng, C., et al.[2023]

Subcutaneous semaglutide (Wegovy) has been shown to significantly reduce body weight in overweight and obese individuals, with a dose-dependent effect observed in four Phase 3 trials involving 5000 participants.

While semaglutide resulted in greater weight loss compared to placebo, gastrointestinal side effects were the most common safety concerns, highlighting the need for further studies in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. Phillips, A., Clements, JN.[2022]

A survey of 127 physicians revealed that many have varying pre-treatment requirements for prescribing semaglutide for weight loss, with 30% requiring a minimum body mass index of 30 kg/m² and 67% expecting documented lifestyle changes.

Despite its effectiveness, over 50% of patients discontinued semaglutide therapy within the first 3 months, primarily due to cost, perceived lack of effectiveness, and concerns about long-term side effects, indicating a need for better patient education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Semaglutide Use for Weight Management: Practice and Attitudes of Physicians in Israel. Dicker, D., Tamir, O., Lieberman-Segal, G., et al.[2023]

In a study involving 2117 participants treated with semaglutide 2.4 mg for 68 weeks, gastrointestinal adverse events (AEs) like nausea and diarrhea were more common than in the placebo group, but these AEs were mostly mild and transient, with only 4.3% of participants discontinuing treatment due to them.

Weight loss with semaglutide was significant and similar in participants with and without GI AEs, indicating that the weight loss effects of semaglutide are largely independent of these gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss. Wharton, S., Calanna, S., Davies, M., et al.[2022]

High-dose once-weekly semaglutide has been shown to significantly reduce weight in patients with obesity or overweight, as demonstrated in four phase 3 clinical trials involving various populations, including those with diabetes.

While gastrointestinal side effects were common, semaglutide was generally well tolerated and also led to improvements in cardiometabolic risk factors, such as waist circumference and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2022]

In a phase 3 trial involving 667 adults with overweight or obesity, oral semaglutide 50 mg taken daily resulted in a significant average weight loss of 15.1% compared to only 2.4% with placebo over 68 weeks, demonstrating its efficacy in weight management.

While semaglutide was effective, it was associated with a higher incidence of adverse events, particularly gastrointestinal issues, affecting 80% of participants, indicating that while it is effective, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Knop, FK., Aroda, VR., do Vale, RD., et al.[2023]

References

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

Effect of semaglutide 2.4 mg once weekly on 10-year type 2 diabetes risk in adults with overweight or obesity. [2023]

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

Efficacy and safety of semaglutide 2.4 mg for weight loss in overweight or obese adults without diabetes: An updated systematic review and meta-analysis including the 2-year STEP 5 trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Clinical review of subcutaneous semaglutide for obesity. [2022]

5. Israel pubmed.ncbi.nlm.nih.gov

Subcutaneous Semaglutide Use for Weight Management: Practice and Attitudes of Physicians in Israel. [2023]

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

Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss. [2022]

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

High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. [2022]

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

Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. [2023]

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

New Indication for Weight Loss Drug Semaglutide. [2023]