1407 Participants Needed

Semaglutide for Weight Loss in Obesity

(STEP UP Trial)

Recruiting at 182 trial locations
NN
Overseen ByNovo Nordisk
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on glucose-lowering medications, you must stop them at least 90 days before the screening.

Is semaglutide safe for weight loss in humans?

Semaglutide has been shown to be generally safe in humans, with studies indicating it is well-tolerated and effective for weight loss and managing type 2 diabetes. It has been tested in various forms, including oral and injectable, and has demonstrated cardiovascular safety comparable to placebo in high-risk patients.12345

How is the drug semaglutide unique for weight loss in obesity?

Semaglutide is unique because it is a once-weekly injection that has shown the largest weight loss of any obesity medication to date, with reductions of about 15% of initial weight over 68 weeks, and it also improves cardiovascular risk factors.14678

What data supports the effectiveness of the drug Semaglutide for weight loss in obesity?

Research shows that Semaglutide, a drug used for type 2 diabetes, also helps with weight loss. In clinical trials, people taking Semaglutide lost more weight than those on other treatments, making it a promising option for managing obesity.12369

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m^2)
History of at least one self-reported unsuccessful dietary effort to lose body weight
I am either male or female.

Exclusion Criteria

I have a history of diabetes.
I have lost or gained more than 11 pounds in the last 3 months.
HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-weekly injections of semaglutide or placebo, with dose escalation over 20 weeks followed by maintenance dosing for a total of 72 weeks

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • Semaglutide
Trial Overview 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.
How Is the Trial Designed?
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.

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇺🇸
Approved in United States as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇨🇦
Approved in Canada as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇯🇵
Approved in Japan as Ozempic for:
  • Type 2 diabetes
  • Cardiovascular disease
  • Obesity
🇺🇸
Approved in United States as Wegovy for:
  • Obesity
🇺🇸
Approved in United States as Rybelsus for:
  • Type 2 diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Published Research Related to This Trial

Semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, has been shown to achieve significant and sustained weight loss in individuals with obesity, surpassing results from previous weight-loss medications, and has been approved for use alongside diet and exercise.
Emerging treatments like tirzepatide and cagrilintide are demonstrating even greater weight loss effects than semaglutide, indicating a shift towards more effective 'weight-centric' strategies for managing obesity and related conditions like type 2 diabetes.
Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer?Colin, IM., Gérard, KM.[2022]
Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.
The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.
[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)].Paquot, N.[2022]
Semaglutide, a GLP-1 receptor agonist with a long half-life, effectively promotes insulin secretion in a glucose-dependent manner, making it a valuable treatment for type 2 diabetes, approved for use worldwide and in Japan since 2018.
Oral semaglutide (Rybelsus®) is the first GLP-1 receptor agonist available in pill form, showing continuous benefits in glycemic control for patients with type 2 diabetes across various stages, as demonstrated in multiple global clinical trials.
[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus® tablets), an oral GLP-1 receptor agonist].Miyasaka, K.[2022]

Citations

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]
[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]
[New drug for type 2 diabetes: introduction of oral Semaglutide (Rybelsus® tablets), an oral GLP-1 receptor agonist]. [2022]
[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]
Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. [2023]
Semaglutide for the treatment of obesity. [2023]
High-Dose Once-Weekly Semaglutide: A New Option for Obesity Management. [2022]
Semaglutide for the treatment of overweight and obesity: A review. [2023]
Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security