A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range

Sponsor
Novo Nordisk A/S
Study ID
NCT06041217
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.
  • Placebo — DRUG
    Subcutaneous injections of placebo once-weekly at escalation doses manner as semaglutide every fourth week until maintenance dose of placebo matched to 2.4 mg is reached.

Study Details

This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.

Key Dates

Start date
Sep 15, 2023
Status verified
Apr 2026
Primary completion
Apr 2, 2025
Completion
May 7, 2025

Study Design

Enrollment
242 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide 2.4 milligram (mg)
    Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.
  • Placebo Comparator: Placebo
    Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.

Primary Outcome Measure

Change in Body Weight (%) [ Time Frame: Baseline (week 0), end of treatment (week 44) ]

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