Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)

(OASIS 1 Trial)

Recruiting at 98 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

667 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing semaglutide tablets to help people with overweight or obesity lose weight. Participants will take either the new medicine or a non-active substance for over a year. Semaglutide helps reduce appetite, making it easier to eat less and lose weight. It has been shown to significantly aid in weight loss and was recently approved for long-term weight management.

Research Team

Clinical Transparency (dept. 1452)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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

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)

Treatment Details

Interventions

• Placebo (semaglutide)
• Semaglutide

Participant Groups

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