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Glucagon-like peptide-1 receptor agonist

Semaglutide 7.2 mg for Type 2 Diabetes

Verified 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

Study Summary

This trial will compare weight loss & blood sugar control in those taking semaglutide vs. "dummy" medicine, with talks on healthy food & physical activity. Participants get semaglutide or "dummy" medicine, by chance, injected under skin with a thin needle. Dose of semaglutide gradually increases until reaching the target. Study lasts 1.5 years.

Eligible Conditions
  • Obesity
  • Type 2 Diabetes

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
+24 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

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 will be 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 will be 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
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,516 Total Patients Enrolled
141 Trials studying Obesity
131,525 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
105 Previous Clinical Trials
139,276 Total Patients Enrolled
28 Trials studying Obesity
49,012 Patients Enrolled for Obesity

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05649137 — Phase 3
Obesity Research Study Groups: Semaglutide 7.2 mg, Semaglutide 2.4 mg, Placebo
Obesity Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05649137 — Phase 3
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05649137 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05649137 — Phase 3

Frequently Asked Questions

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

What safety protocols should be followed when taking Semaglutide 7.2 mg?

"Our experts at Power have concluded that Semaglutide 7.2 mg is reasonably safe, awarding it a rating of 3 on the scale due to evidence from Phase 3 trials and subsequent confirmations of its safety profile."

Answered by AI

How many centers are responsible for the administration of this clinical trial?

"Currently, this clinical trial is enrolling patients from 27 distinct sites in the US. These locations encompass Jacksonville, Oviedo and Los Angeles plus another 24 facilities. To reduce any burdensome travel requirements it is sensible to select a site near your current location."

Answered by AI

What key goals is this research attempting to pursue?

"The primary aim of this trial, spanning from baseline (week 0) to end of treatment (week 72), is to assess the number of patients that experience a 5% or more reduction in body weight when given Semaglutide 7.2 mg compared with those receiving Placebo. Secondary outcomes consist of an assessment on the amount participants undergoing 15% or more decrease in body mass, alteration in waist circumference measured by centimetres and the quantity of individuals who acquire HbA1c levels lower than 6.5 % (48 mmol/mol)."

Answered by AI

Are there any vacancies left for this medical experiment?

"According to clinicaltrials.gov, this particular medical trial is no longer recruiting participants and has not been updated since December 5th 2022. Fortunately, there are approximately 2280 trials worldwide currently accepting patients at the moment."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Illinois
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?
Other
Novo Nordisk Investigational Site
Novo Nordisk Investigational Site - Sugar Land
Novo Nordisk Investigational Site - Austin

Why did patients apply to this trial?

Type 2 and fat. To loose weight. Ad from Facebook. Need to loose weight. I need to lose weight.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long is the trial? How long does this study run? Is it possible to get a placebo?
PatientReceived 2+ prior treatments
What is the overall goal of this study? How long is the trial? How many visits needed?
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Novo Nordisk Investigational Site - Sugar Land: < 24 hours
  2. Novo Nordisk Investigational Site - Austin: < 24 hours
Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
2023. "A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05649137.
~122 spots leftby Oct 2024
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