A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

Obesity Clinical Trial

— STEP UP  

Official title:

Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05646706
• Other study ID #: NN9536-4999
• Secondary ID: U1111-1274-42592
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 4, 2023
• Est. completion date: November 22, 2024

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1407
• Est. completion date: November 22, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female.
• Age above or equal to 18 years at the time of signing informed consent.
• 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.

Exclusion Criteria:

• HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening.
• History of type 1 or type 2 diabetes.
• Treatment with glucose-lowering agent(s) within 90 days before screening.
• A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening irrespective of medical records.
• Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Semaglutide
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 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. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
• Semaglutide
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
• Placebo
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Locations

Country	Name	City	State
Bulgaria	Medical centre "Zdrave 1" OOD	Kozloduy
Bulgaria	Medical center Hippocrates-Lukovit	Lukovit
Bulgaria	Individual Practice for medical care -Dr Elizabeta Dimitrova	Petrich
Bulgaria	"Medical center Smolyan clinical research" OOD	Smolyan
Bulgaria	Acibadem City Clinic MHAT Tokuda Department of Endocrinology	Sofia
Bulgaria	Diagnostic Consulting Center Ascendent	Sofia
Bulgaria	Medical centre "Medical arts medico-dental centre"	Sofia
Bulgaria	Specialized gynaecology hospital for active treatment Dr Shterev	Sofia
Bulgaria	"Ambulatory for individual practice and specialized medical care Dr. Evelina Zlatanova" EOOD	Varna
Bulgaria	"Medical Center Medical Plus" Eood	Varna
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Nova Scotia Hlth Halifax	Halifax	Nova Scotia
Canada	Hamilton Med Res Group	Hamilton	Ontario
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	Milestone Research	London	Ontario
Canada	Ocean West Research Clinic	Surrey	British Columbia
Czechia	Ordinace praktického lékare	Benátky Na Jizerou
Czechia	Edumed Broumov	Broumov
Czechia	Fledip s.r.o.	Praha
Czechia	Fakultní nemocnice Královské Vinohrady_Praha 10	Praha 10
Czechia	Endocare	Praha 4
Czechia	Institut klinické a experimentalni mediciny	Praha 4
Czechia	Poliklinika Michnova - Obezitologie	Praha 4
Germany	Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR	Berlin
Germany	Zentrum fuer klinische Studien Suedbrandenburg GmbH	Elsterwerda
Germany	InnoDiab Forschung GmbH	Essen
Germany	Praxis Dr. med. M. Esser	Essen
Germany	Zentrum für klinische Forschung, Dr. med. Lüdemann	Falkensee
Germany	MedicalCenter am Clemenshospital	Münster
Germany	RED-Institut für medizinische Forschung und Fortbildung GmbH	Oldenburg in Holstein
Germany	Praxis Dr. med. Wenzl-Bauer	Rehlingen-Siersburg
Germany	Zentrum für klinische Studien Allgäu Oberschwaben	Wangen
Germany	Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann	Witten
Greece	Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter	Athens
Greece	Iatriko Athinon 'Palaiou Falirou'	Athens
Greece	Iatriko Athinon (Athens Medical Canter)	Athens
Greece	University Hospital of Athens ATTIKON	Haidari-Athens
Greece	General Hospital of Lamia	Lamia
Greece	"Ippokrateio" G.H. of Thessaloniki	Thessaloniki
Greece	"Thermi" Private Hosital	Thessaloniki
Greece	AHEPA General University Hospital	Thessaloniki
Greece	General Hospital of Thessaloniki 'G. Gennimatas	Thessaloniki
Hungary	Lausmed Kft.	Baja	Bács-Kiskun Vármegye
Hungary	Bajcsy-Zsilinszky Kórház	Budapest
Hungary	ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.	Budapest
Hungary	MED-TIMA Kft.	Budapest
Hungary	Belinus Bt.	Debrecen	Hajdu-Bihar Varmegye
Hungary	Borbánya Praxis E.Ü. Kft.	Nyíregyháza	Szabolcs-Szatmar Varmegye
Hungary	Fejér Megyei Szent György Oktatókórház	Székesfehérvár
Norway	Falck Norge AS	Hamar
Norway	Oslo universitetssykehus HF Aker	Oslo
Norway	Sykehuset i Vestfold HF, Tønsberg	Tønsberg
Poland	Kresmed Sp. z o. o.	Bialystok	Podlaskie
Poland	Centrum Medyczne Pratia Gdynia	Gdynia	Pomorskie
Poland	Uniwersyteckie Centrum Kliniczne SUM w Katowicach	Katowice
Poland	Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET	Krakow	Malopolskie
Poland	NZOZ "CenterMed Lublin" Sp. z o.o.	Lublin	Lubelskie
Poland	NZOZ Przychodnia Specjalistyczna Medica	Lublin	Lubelski
Poland	NBR Polska Tomasz Klodawski	Warszawa
Poland	PANSTWOWY INSTYTUT MEDYCZNY MSWiA	Warszawa
Portugal	APDP - Associação Protectora dos Diabéticos de Portugal	Lisboa
Portugal	Unidade Local de Saúde de Matosinhos	Matosinhos
Portugal	Centro Hospitalar de São João	Porto
Slovakia	MEDIMAD, s.r.o., Endokrinologicka ambulancia	Bratislava
Slovakia	MUDr. Dagmar Prokesova, Endokrinologicka ambulancia	Bratislava
Slovakia	Diabetologicka ambulancia IN-DIA s.r.o.	Lucenec
Slovakia	SIN AZUCAR s.r.o.	Malacky
Slovakia	MED-CENTRUM, s.r.o.	Martin
Slovakia	SVAJDLEROVA, s.r.o.	Presov
Slovakia	Dom srdca, s.r.o.	Zilina
Slovakia	MEDIVASA, s.r.o., Angiologicka ambulancia	Zilina
South Africa	Medi-Clinic Bloemfontein	Bloemfontein	Free State
South Africa	Dr N.K. Gounden Medical Centre	Durban	KwaZulu Natal
South Africa	Maxwell Centre	Durban	KwaZulu-Natal
South Africa	Deepak Lakha	Johannesburg	Gauteng
South Africa	Hemant Makan	Johannesburg	Gauteng
South Africa	Soweto Clinical Trial Centre	Johannesburg	Gauteng
South Africa	Wits Bara Clinical Trial Site	Johannesburg	Gauteng
South Africa	Phoenix Pharma	Port Elizabeth	Eastern Cape
South Africa	Dr T Padayachee	Umkomaas	KwaZulu-Natal
United States	Amarillo Med Spec LLP	Amarillo	Texas
United States	Elligo Clin Res Centre	Austin	Texas
United States	Univ of Alabama Birmingham	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	UT Southwestern Medical Center-CRU	Dallas	Texas
United States	Velocity Clin Res, Dallas	Dallas	Texas
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	East West Med Res Inst	Honolulu	Hawaii
United States	Midwest Inst For Clin Res	Indianapolis	Indiana
United States	Jacksonville Ctr For Clin Res	Jacksonville	Florida
United States	DCOL Ctr for Clin Res	Longview	Texas
United States	Healthscan Clinical Trials,LLC.	Montgomery	Alabama
United States	Florida Inst For Clin Res LLC	Orlando	Florida
United States	Florida Institute For Clinical Research LLC	Orlando	Florida
United States	National Clin Res Inc.	Richmond	Virginia
United States	Sugar Lakes Family Practice PA	Sugar Land	Texas
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Selma Medical Associates	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Germany,  Greece,  Hungary,  Norway,  Poland,  Portugal,  Slovakia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semaglutide 7.2 mg versus Placebo: Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Primary	Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=25% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in waist circumference	Measured in centimeters (cm).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=20% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=25% (yes/no)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in body weight	Measured in kilograms (kg).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)	Measured in kilogram per square meter (kg/m^2).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in total fat mass (%)	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in total fat mass (liters)	Measured in liters.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in lean body mass (%)	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in lean body mass (liters)	Measured in liters.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (%)	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (liters)	Measured in liters.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure	Measured in mmHg.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in total cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in very low-density lipoprotein (VLDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in triglycerides	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in free fatty acids	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP)	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Number of participants with change in lipid-lowering treatment (decrease, no change, increase)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Number of participants with change in antihypertensive treatment (decrease, no change, increase)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose	Measured in milligrams per deciliter (mg/dL).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Number of participants with change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D])	Measured as count of participants.	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)	Measured as count of events.	From baseline (week 0) to end of study (week 81)
Secondary	Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)	Measured as count of events.	From baseline (week 0) to end of study (week 81)
Secondary	Semaglutide 7.2 mg versus Placebo: Change in pulse	Measured in beats per minute (bmp).	From baseline (week 0) to end of treatment (week 72)
Secondary	Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs	Measured as count of events.	From baseline (week 0) to end of study (week 81)
Secondary	Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs	Measured as count of events.	From baseline (week 0) to end of study (week 81)