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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

Pivotal Trial

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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%

Study treatment Arm

Overall Study

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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