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Glucagon-like peptide-1 receptor agonist

Semaglutide s.c. 2.4 mg once weekly for Obesity (STEP 1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) to week 75
Awards & highlights

STEP 1 Trial Summary

This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, 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 has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.

Eligible Conditions
  • Metabolic and Nutritional Disorders
  • Obesity

STEP 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) to week 75
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) to week 75 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Body Weight (%)
Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)
Secondary outcome measures
Change in Amylase - Ratio to Baseline
Change in Body Composition (Lean Body Mass) (%)
Change in Body Composition (Lean Body Mass) (kg)
+37 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

STEP 1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide s.c. 2.4 mg once weeklyExperimental Treatment1 Intervention
Participants will receive semaglutide for 68 weeks.
Group II: Semaglutide placeboPlacebo Group1 Intervention
Participants will receive semaglutide matching placebo for 68 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,525 Previous Clinical Trials
2,417,739 Total Patients Enrolled
144 Trials studying Obesity
130,489 Patients Enrolled for Obesity
Clinical Reporting Anchor and Disclosure (1452)Study DirectorNovo Nordisk A/S
104 Previous Clinical Trials
101,293 Total Patients Enrolled
28 Trials studying Obesity
41,677 Patients Enrolled for Obesity
~280 spots leftby Jun 2025