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Glucagon-like peptide-1 receptor agonist

Semaglutide for Weight Loss in Obesity (STEP UP 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 from baseline (week 0) to end of study (week 81)
Awards & highlights

STEP UP Trial Summary

This trial looks at how much weight participants will lose taking a high dose of semaglutide or a "dummy" medicine, and will include talks about healthy food choices and physical activity. Participants get the medicine via injection, and the trial lasts over 6 months.

Who is the study for?
This trial is for adults with obesity (BMI ≥ 30 kg/m²) who have tried and failed to lose weight through dieting. It's not open to people with a personal or family history of certain thyroid cancers, those treated with diabetes medications recently, or anyone whose weight changed by more than 11 pounds in the last 90 days.Check my eligibility
What is being tested?
The study tests high doses of Semaglutide against a placebo ('dummy' medicine) and a lower dose of Semaglutide for weight loss. Participants will also receive guidance on healthy eating and exercise. Treatment allocation is random, with a higher chance of receiving Semaglutide.See study design
What are the potential side effects?
Semaglutide may cause digestive issues like nausea, vomiting, diarrhea; possible risk of low blood sugar; injection site reactions; and rare but serious side effects such as pancreatitis or thyroid tumors.

STEP UP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 81)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of study (week 81) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)
Semaglutide 7.2 mg versus Placebo: Relative change in body weight
Secondary outcome measures
Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)
Semaglutide 7.2 mg versus Placebo: Change in body weight
Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure
+33 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 UP Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide 7.2 mgExperimental Treatment1 Intervention
Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.
Group II: Semaglutide 2.4 mgExperimental Treatment1 Intervention
Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 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
1,518 Previous Clinical Trials
2,414,523 Total Patients Enrolled
143 Trials studying Obesity
130,976 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
109 Previous Clinical Trials
139,105 Total Patients Enrolled
29 Trials studying Obesity
48,409 Patients Enrolled for Obesity

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05646706 — Phase 3
Obesity Research Study Groups: Placebo, Semaglutide 7.2 mg, Semaglutide 2.4 mg
Obesity Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05646706 — Phase 3
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05646706 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05646706 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration authorized Semaglutide 2.4 mg as safe to use?

"We have judged semaglutide 2.4 mg to be a safety level 3 due to the available evidence from Phase III clinical trials, which provides proof of efficacy and multiple rounds verifying its security."

Answered by AI

Are there vacancies available for people to join this clinical trial?

"According to the information published on clinicaltrials.gov, this medical trial is not presently seeking participants. Even though it was initially posted on April 1st 2023 and last updated December 2nd 2022, recruitment has since been concluded yet 962 other trials are still open for enrolment."

Answered by AI

In how many healthcare centers is this experiment being conducted?

"Currently, 22 clinical centres across the country are running this trial; notable cities include Montgomery, Greensboro and Jacksonville. For convenience sake, it is best to register at a facility close-by as travel demands may be decreased."

Answered by AI

What is the desired outcome of this clinical research?

"The principal outcome of this investigation will be evaluated from baseline (week 0) to the end of treatment (week 72), and it is focused on determining how many participants experience a body weight reduction higher than or equal to 5%. Additionally, secondary outcomes include changes in total fat mass, pulse rate, and fasting plasma glucose."

Answered by AI

Who else is applying?

What state do they live in?
New York
North Carolina
Other
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0
What site did they apply to?
Novo Nordisk Investigational Site
Other

Why did patients apply to this trial?

I'm struggling to lose weight. I've tried to lose weight but it didn't work.
PatientReceived 2+ prior treatments
I have tried dieting and need help losing the last 25 pounds. I am hoping to find a medication to get my weight decreased.
PatientReceived no prior treatments
I've tried for 20 years to lose weight and nothing has worked.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does it last? How much time is involved? How long till screening and when?
PatientReceived no prior treatments
Will I be notified if I am not a good candidate? How often are visits? What are the odds of placebo? Do you offer an OLE for those who received a placebo?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
2023. "A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05646706.
All > Paid Studies Honolulu
~211 spots leftby Sep 2024
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