What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as Semaglutide, are commonly used for obesity treatment and have several known side effects. These include gastrointestinal issues like nausea, vomiting, and diarrhea, which are typically more pronounced at the beginning of the treatment. There is also a potential risk for pancreatitis and, in rare cases, pancreatic cancer. Additionally, these medications may cause benign and malignant thyroid C cell tumors, particularly in individuals with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome types 2A or 2B. Other common obesity treatments, such as phentermine-topiramate, can cause side effects like dry mouth, constipation, insomnia, and an increased heart rate.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity. Semaglutide, a GLP-1 receptor agonist, has been approved for weight management in adults with obesity or overweight with at least one weight-related condition. Other similar drugs include liraglutide, which is also approved for chronic weight management in adults and adolescents with obesity. These medications work by mimicking the incretin hormone GLP-1, which helps regulate appetite and food intake, leading to significant weight loss in clinical trials.

What other types of research exist?

Promising alternatives to Semaglutide for obesity treatment in 2024 include: 1) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown significant weight loss in clinical trials. 2) Liraglutide, another GLP-1 receptor agonist, already approved for weight management. 3) Emerging therapies such as Setmelanotide, a melanocortin 4 receptor agonist, for specific genetic obesity conditions. These alternatives offer different mechanisms of action and have demonstrated efficacy in weight reduction.

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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

Pivotal Trial

Summary

This trial is testing a new weight loss drug called semaglutide on overweight or obese individuals. The drug helps reduce hunger and increase fullness, promoting weight loss. Participants' progress will be monitored over a period of time. Semaglutide is a long-acting GLP-1 receptor agonist that has been shown to induce significant weight loss in individuals with obesity or overweight.

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.

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.

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.

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

+33 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 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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as Semaglutide, work by mimicking the incretin hormone GLP-1, which is released after eating. These medications enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and increase satiety, leading to reduced food intake and weight loss. This mechanism is particularly important for obesity patients as it addresses both appetite control and metabolic regulation, making it easier for them to achieve and maintain weight loss. Additionally, the weight loss benefits are often accompanied by improvements in blood glucose levels, which is crucial for patients with or at risk of type 2 diabetes.