Semaglutide for Obesity

(OASIS 1 Trial)

No longer recruiting at 113 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Disqualifiers: Diabetes, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 68 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if semaglutide tablets can aid weight loss in individuals who are overweight or living with obesity. Participants will take either semaglutide tablets or placebo tablets (inactive pills) daily for 68 weeks. The study will also provide guidance on healthy eating and exercise. It suits individuals who have struggled with weight loss, have a BMI over 27, and experience related health issues such as high blood pressure or sleep apnea. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study doctor to get a clear answer.

Is there any evidence suggesting that semaglutide tablets are likely to be safe for humans?

Research has shown that oral semaglutide is generally well-tolerated, with a safety profile similar to other GLP-1 receptor agonists, which help control blood sugar in people with type 2 diabetes.

Semaglutide, when taken orally, rarely causes low blood sugar (hypoglycemia), a common concern with diabetes treatments. Some individuals may experience side effects like nausea, but these are usually mild and tend to decrease over time.

Importantly, the FDA has already approved semaglutide for treating type 2 diabetes, indicating it has passed safety checks for that purpose. However, this study uses higher doses than those for diabetes, so the trial will confirm its safety at these levels for weight loss. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for obesity, which often includes injectable medications like liraglutide, semaglutide tablets offer a convenient oral delivery method. This is a big deal because taking a pill is generally easier and more comfortable than getting a shot. Additionally, semaglutide works by mimicking the GLP-1 hormone, which helps control appetite and blood sugar, potentially offering superior weight management compared to some existing options. Researchers are excited because this approach could lead to better adherence and outcomes for people struggling with weight issues.

What evidence suggests that semaglutide tablets might be an effective treatment for overweight or obesity?

Research has shown that semaglutide tablets can help people lose weight. In this trial, participants will receive either oral semaglutide or a placebo. One study found that people taking semaglutide pills lost about 3.8 kg more than those taking a placebo, which is a fake pill. This difference is significant. Other studies have also shown that semaglutide helps lower body weight and improve blood sugar levels. In everyday use, people taking semaglutide experienced an average weight loss of 2%. These findings suggest that semaglutide effectively helps people manage their weight. ^{1 6 7 8 9}

Who Is on the Research Team?

Clinical Transparency (dept. 1452)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

Inclusion Criteria

greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m^2

You have tried to lose weight through a diet before, but it was not successful.

Body mass index (BMI): greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m^2

Exclusion Criteria

You have gained or lost more than 11 pounds (5 kilograms) in the last 90 days, regardless of medical records.

HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive semaglutide or placebo tablets for 68 weeks, with dose escalation for semaglutide

68 weeks

14 clinic visits, 7 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebo (semaglutide)
• Semaglutide

How Is the Trial Designed?

Group I: Oral semaglutide Experimental Treatment 1 Intervention

Participants will receive once daily semaglutide tables in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68)

Group II: Oral semaglutide placebo Placebo Group 1 Intervention

All participants are given once daily dose for 68 weeks

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Wegovy for:

• Obesity

Approved in United States as Rybelsus for:

• Type 2 diabetes

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/PMC8217049/

A Pharmacological and Clinical Overview of Oral ... Oral semaglutide (14 mg) also provided a significantly greater body weight reduction compared with placebo (ETD − 3.8 kg; p < 0.001) and liraglutide (1.8 mg) at ...

2. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/756-P/158832/756-P-Real-World-Data-Comparing-the-Effectiveness

756-P: Real-World Data Comparing the Effectiveness of ... The effectiveness of oral and injectable semaglutide on other outcomes were comparable. The mean follow-up time was 413 +/-342 days in oral ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1901118

Oral Semaglutide and Cardiovascular Outcomes in ... Oral semaglutide reduced glycated hemoglobin levels and body weight in the present trial, which is consistent with the phase 3a efficacy and safety trial ...

4. medcentral.com medcentral.com/endocrinology/diabetes/semaglutide-wins-cv-nod-as-approval-as-the-first-oral-glp-1-for-obesity-nears

Oral Semaglutide Wins Cardiovascular Approval as FDA ... The primary endpoint, MACE, occurred in 12.0% of semaglutide patients vs. 13.8% of placebo, corresponding to a 14% relative risk reduction. The ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0149291824003308

Review Real-world Evidence on Oral Semaglutide for the ... In real-world settings, oral semaglutide provided significant glycemic (median HbA1c reduction at 6 months of 1%) and weight (median body weight reduction of 2 ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603723/

Semaglutide - StatPearls - NCBI Bookshelf Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is approved by the US Food and Drug Administration (FDA) as 3 separate brand name medications.

7. tctmd.com tctmd.com/news/oral-semaglutide-gets-fda-approval-cv-event-reduction-high-risk-diabetes-patients

Oral Semaglutide Gets FDA Approval for CV Event ... In SOUL, the overall safety profile of oral semaglutide was in line with what had been seen in prior trials, Novo Nordisk said. Serious adverse ...

8. novomedlink.com novomedlink.com/obesity/products/treatments/wegovy/efficacy-safety/safety-profile.html

Wegovy® Safety Profile Learn about the safety profile of Wegovy® after being evaluated in clinical studies. Read Important Safety and Prescribing Info, including Boxed Warning.

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/213051s018lbl.pdf

RYBELSUS tablets - accessdata.fda.gov See full prescribing information for RYBELSUS. RYBELSUS (semaglutide) tablets, for oral use. Initial U.S. Approval: 2017. WARNING: RISK OF THYROID C-CELL TUMORS.