Clinical trial

Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity

Name

NN9932-4954

Description

This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.

Trial arms

Trial start

2022-10-11

Estimated PCD

2024-04-11

Trial end

2024-05-07

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Semaglutide

Semaglutide tablets orally once daily for 64 weeks.

Arms:

Oral semaglutide 25 mg

Placebo semaglutide

Semaglutide placebo-matching tablets orally once daily for 64 weeks.

Arms:

Oral semaglutide placebo

Size

281

Primary endpoint

Relative change in body weight

From baseline (week 0) to end of treatment (week 64)

Number of participants who achieve body weight loss equal to or above 5 percent (yes/no)

At end of treatment (week 64)

Eligibility criteria

Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study * Male or female, age greater than or equal to 18 years at the time of signing informed consent * Body mass index (BMI) of * 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 (CV) disease OR * Greater than or equal to 30.0 kg/m\^2 * History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: * A self-reported change in body weight greater than 5 kg (11 pound \[lbs\]) within 90 days before screening irrespective of medical records * HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 281, 'type': 'ACTUAL'}}

Updated at

2024-05-07

1 organization

2 products

1 indication

Organization

Product

Indication

Product