Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT05564117
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Semaglutide — DRUG
    Semaglutide tablets orally once daily for 64 weeks.
  • Placebo semaglutide — DRUG
    Semaglutide placebo-matching tablets orally once daily for 64 weeks.

Study Details

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.

Key Dates

Start date
Oct 11, 2022
Status verified
Feb 2026
Primary completion
Apr 18, 2024
Completion
May 7, 2024

Study Design

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

Arms

  • Experimental: Oral semaglutide 25 mg
    Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64).
  • Placebo Comparator: Oral semaglutide placebo
    Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.

Primary Outcome Measure

Percentage Change in Body Weight [ Time Frame: Baseline (week 0), end of treatment (week 64) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Univsty Of AL At BirminghamBirminghamAlabama35294-
FDRCCosta MesaCalifornia92627-
East West Medical Research Institute_HonoluluHonoluluHawaii96814-
AccellacareWilmingtonNorth Carolina28401-
UT Southwestern Med CntrDallasTexas75390-9302-
Washington Cntr Weight MgmtArlingtonVirginia22206-
Selma Medical AssociatesWinchesterVirginia22601-

Related coverage on Hipa.ai

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Obesity / overweight
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EndocrinologyMetabolic healthWeight loss
By research site
Univsty Of AL At Birmingham· Birmingham, ALFDRC· Costa Mesa, CAEast West Medical Research Institute_Honolulu· Honolulu, HIAccellacare· Wilmington, NCUT Southwestern Med Cntr· Dallas, TXWashington Cntr Weight Mgmt· Arlington, VA

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