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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week 0) to end of study (week 81)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 81)
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 moreSide effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
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
2021
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,520 Previous Clinical Trials
2,415,852 Total Patients Enrolled
143 Trials studying Obesity
131,870 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
109 Previous Clinical Trials
139,999 Total Patients Enrolled
29 Trials studying Obesity
49,303 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been living with type 2 diabetes for at least 6 months.Anyone can participate regardless of gender.You are 18 years old or older and have given permission to participate in the study.Your body mass index (BMI) of 30 or higher.Your blood test shows that your average blood sugar level (HbA1c) is between 7.0-10.0 percent (53-86 mmol/mol).You have tried to lose weight before, but have not been successful.You have been diagnosed with type 2 diabetes at least 6 months before the screening date.
Research Study Groups:
This trial has the following groups:- Group 1: Semaglutide 7.2 mg
- Group 2: Semaglutide 2.4 mg
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05649137 — Phase 3
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