Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT03693430
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Semaglutide — DRUG
    Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
  • Placebo (Semaglutide) — DRUG
    S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks

Study Details

This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.

Key Dates

Start date
Oct 5, 2018
Status verified
Jul 2023
Primary completion
Jan 29, 2021
Completion
Mar 23, 2021

Study Design

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

Arms

  • Experimental: Semaglutide
    Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
  • Placebo Comparator: Placebo
    Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Primary Outcome Measure

Percentage Change From Baseline (Week 0) to Week 104 in Body Weight [ Time Frame: From Baseline (Week 0) to Week 104 ]

Locations (15)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteBirminghamAlabama35222-
Novo Nordisk Investigational SiteLos AngelesCalifornia90057-
Novo Nordisk Investigational SiteAuroraColorado80045-
Novo Nordisk Investigational SiteGoldenColorado80401-
Novo Nordisk Investigational SiteWaterburyConnecticut06708-
Novo Nordisk Investigational SiteJacksonvilleFlorida32205-
Novo Nordisk Investigational SiteOcalaFlorida34471-
Novo Nordisk Investigational SiteCity of Saint PetersMissouri63303-
Novo Nordisk Investigational SiteButteMontana59701-
Novo Nordisk Investigational SiteAlbanyNew York12203-
Novo Nordisk Investigational SiteRochesterNew York14609-
Novo Nordisk Investigational SiteKingsportTennessee37660-
Novo Nordisk Investigational SiteAustinTexas78731-
Novo Nordisk Investigational SiteRound RockTexas78681-
Novo Nordisk Investigational SiteArlingtonVirginia22206-

Find similar trials in Birmingham, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Birmingham, ALNovo Nordisk Investigational Site· Los Angeles, CANovo Nordisk Investigational Site· Aurora, CONovo Nordisk Investigational Site· Golden, CONovo Nordisk Investigational Site· Waterbury, CTNovo Nordisk Investigational Site· Jacksonville, FL

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