Clinical trial NCT05646706: A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
Official title: Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 1407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Semaglutide 7.2 mg versus Placebo: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
Secondary outcomes:
measure: Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=25% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=20% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=25% (yes/no)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in total fat mass (%)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in total fat mass (liters)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in lean body mass (%)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in lean body mass (liters)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (%)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (liters)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in very low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in free fatty acids
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants with change in lipid-lowering treatment (decrease, no change, increase)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants with change in antihypertensive treatment (decrease, no change, increase)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of participants with change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D])
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)
timeFrame: From baseline (week 0) to end of study (week 81)
measure: Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)
timeFrame: From baseline (week 0) to end of study (week 81)
measure: Semaglutide 7.2 mg versus Placebo: Change in pulse
timeFrame: From baseline (week 0) to end of treatment (week 72)
measure: Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs
timeFrame: From baseline (week 0) to end of study (week 81)
measure: Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs
timeFrame: From baseline (week 0) to end of study (week 81)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama Birmingham
state: Alabama
city: Montgomery
country: United States
facility: Healthscan Clinical Trials,LLC.
state: Alabama
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Jacksonville
country: United States
facility: Jacksonville Ctr For Clin Res
state: Florida
city: Orlando
country: United States
facility: Florida Inst For Clin Res LLC
state: Florida
city: Orlando
country: United States
facility: Florida Institute For Clinical Research LLC
state: Florida
city: Honolulu
country: United States
facility: East West Med Res Inst
state: Hawaii
city: Indianapolis
country: United States
facility: Midwest Inst For Clin Res
state: Indiana
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Amarillo
country: United States
facility: Amarillo Med Spec LLP
state: Texas
city: Austin
country: United States
facility: Elligo Clin Res Centre
state: Texas
city: Dallas
country: United States
facility: Velocity Clin Res, Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center-CRU
state: Texas
city: Longview
country: United States
facility: DCOL Ctr for Clin Res
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice PA
state: Texas
city: Richmond
country: United States
facility: National Clin Res Inc.
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Kozloduy
country: Bulgaria
facility: Medical centre "Zdrave 1" OOD
city: Lukovit
country: Bulgaria
facility: Medical center Hippocrates-Lukovit
city: Petrich
country: Bulgaria
facility: Individual Practice for medical care -Dr Elizabeta Dimitrova
city: Smolyan
country: Bulgaria
facility: "Medical center Smolyan clinical research" OOD
city: Sofia
country: Bulgaria
facility: Diagnostic Consulting Center Ascendent
city: Sofia
country: Bulgaria
facility: Specialized gynaecology hospital for active treatment Dr Shterev
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic MHAT Tokuda Department of Endocrinology
city: Sofia
country: Bulgaria
facility: Medical centre "Medical arts medico-dental centre"
city: Varna
country: Bulgaria
facility: "Medical Center Medical Plus" Eood
city: Varna
country: Bulgaria
facility: "Ambulatory for individual practice and specialized medical care Dr. Evelina Zlatanova" EOOD
city: Surrey
country: Canada
facility: Ocean West Research Clinic
state: British Columbia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Hlth Halifax
state: Nova Scotia
city: Hamilton
country: Canada
facility: Premier Clinical Trial Research Network (PCTRN)
state: Ontario
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Med Res Group
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Benátky Na Jizerou
country: Czechia
facility: Ordinace praktického lékaře
city: Broumov
country: Czechia
facility: Edumed Broumov
city: Praha 10
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady_Praha 10
city: Praha 4
country: Czechia
facility: Endocare
city: Praha 4
country: Czechia
facility: Institut klinické a experimentalni mediciny
city: Praha 4
country: Czechia
facility: Poliklinika Michnova - Obezitologie
city: Praha
country: Czechia
facility: Fledip s.r.o.
city: Berlin
country: Germany
facility: Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
city: Elsterwerda
country: Germany
facility: Zentrum fuer klinische Studien Suedbrandenburg GmbH
city: Essen
country: Germany
facility: InnoDiab Forschung GmbH
city: Essen
country: Germany
facility: Praxis Dr. med. M. Esser
city: Falkensee
country: Germany
facility: Zentrum für klinische Forschung, Dr. med. Lüdemann
city: Münster
country: Germany
facility: MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut für medizinische Forschung und Fortbildung GmbH
city: Rehlingen-Siersburg
country: Germany
facility: Praxis Dr. med. Wenzl-Bauer
city: Wangen
country: Germany
facility: Zentrum für klinische Studien Allgäu Oberschwaben
city: Witten
country: Germany
facility: Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann
city: Athens
country: Greece
facility: University Hospital of Athens ATTIKON
state: Attica
city: Athens
country: Greece
facility: Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
city: Athens
country: Greece
facility: Iatriko Athinon (Athens Medical Canter)
city: Athens
country: Greece
facility: Iatriko Athinon 'Palaiou Falirou'
city: Lamia
country: Greece
facility: General Hospital of Lamia
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki 'G. Gennimatas
city: Thessaloniki
country: Greece
facility: AHEPA General University Hospital
city: Thessaloniki
country: Greece
facility: "Ippokrateio" G.H. of Thessaloniki
city: Thessaloniki
country: Greece
facility: "Thermi" Private Hosital
city: Baja
country: Hungary
facility: Lausmed Kft.
state: Bács-Kiskun Vármegye
city: Debrecen
country: Hungary
facility: Belinus Bt.
state: Hajdu-Bihar Varmegye
city: Nyíregyháza
country: Hungary
facility: Borbánya Praxis E.Ü. Kft.
state: Szabolcs-Szatmar Varmegye
city: Budapest
country: Hungary
facility: ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház
city: Budapest
country: Hungary
facility: MED-TIMA Kft.
city: Székesfehérvár
country: Hungary
facility: Fejér Megyei Szent György Oktatókórház
city: Hamar
country: Norway
facility: Falck Norge AS
city: Oslo
country: Norway
facility: Oslo universitetssykehus HF Aker
city: Tønsberg
country: Norway
facility: Sykehuset i Vestfold HF, Tønsberg
city: Lublin
country: Poland
facility: NZOZ "CenterMed Lublin" Sp. z o.o.
state: Lubelskie
city: Lublin
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Medica
state: Lubelski
city: Krakow
country: Poland
facility: Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
state: Malopolskie
city: Bialystok
country: Poland
facility: Kresmed Sp. z o. o.
state: Podlaskie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
state: Pomorskie
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne SUM w Katowicach
city: Warszawa
country: Poland
facility: NBR Polska Tomasz Klodawski
city: Warszawa
country: Poland
facility: PANSTWOWY INSTYTUT MEDYCZNY MSWiA
city: Senhora Da Hora, Matosinhos
country: Portugal
facility: Unidade Local De Saude De Matosinhos E.P.E.
state: Matosinhos
city: Lisboa
country: Portugal
facility: APDP - Associação Protectora dos Diabéticos de Portugal
city: Porto
country: Portugal
facility: Unidade Local de Saude de Sao Joao E.P.E
city: Bratislava
country: Slovakia
facility: MUDr. Dagmar Prokesova, Endokrinologicka ambulancia
city: Bratislava
country: Slovakia
facility: MEDIMAD, s.r.o., Endokrinologicka ambulancia
city: Lucenec
country: Slovakia
facility: IN-DIA s.r.o.
city: Malacky
country: Slovakia
facility: SIN AZUCAR s.r.o.
city: Martin
country: Slovakia
facility: MED-CENTRUM, s.r.o.
city: Presov
country: Slovakia
facility: SVAJDLEROVA, s.r.o.
city: Zilina
country: Slovakia
facility: MEDIVASA, s.r.o., Angiologicka ambulancia
city: Zilina
country: Slovakia
facility: Dom srdca, s.r.o.
city: Port Elizabeth
country: South Africa
facility: Phoenix Pharma
state: Eastern Cape
city: Bloemfontein
country: South Africa
facility: Medi-Clinic Bloemfontein
state: Free State
city: Johannesburg
country: South Africa
facility: Soweto Clinical Trial Centre
state: Gauteng
city: Johannesburg
country: South Africa
facility: Deepak Lakha
state: Gauteng
city: Johannesburg
country: South Africa
facility: Hemant Makan
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Bara Clinical Trial Site
state: Gauteng
city: Durban
country: South Africa
facility: Dr N.K. Gounden Medical Centre
state: KwaZulu Natal
city: Durban
country: South Africa
facility: Maxwell Centre
state: KwaZulu-Natal
city: Umkomaas
country: South Africa
facility: Dr T Padayachee
state: KwaZulu-Natal
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: