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

Conditions

• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Oral semaglutide — DRUG
  Participants will receive a daily dose of oral semaglutide.
• Placebo (semaglutide) — DRUG
  Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.

Study Details

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

Key Dates

Start date

Sep 13, 2021

Status verified

Apr 2026

Primary completion

Mar 24, 2023

Completion

May 12, 2023

Study Design

Enrollment

667 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Oral semaglutide
  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)
• Placebo Comparator: Oral semaglutide placebo
  All participants are given once daily dose for 68 weeks

Primary Outcome Measure

Percentage Change in Body Weight [ Time Frame: Baseline (week 0), end-of-treatment (week 68) ]

Locations (13)

Related coverage on Hipa.ai

• Semaglutide Oral Tablet Shows Significant Weight Loss in Obesity Trial
  Semaglutide · May 7, 2026 · ClinicalTrials.gov

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