A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
NCT ID: NCT05649137
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
512 participants
INTERVENTIONAL
2023-01-04
2024-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Semaglutide 7.2 mg
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.
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 will be 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 2.4 mg
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.
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 will be 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.
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.
Interventions
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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 will be 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 will be 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.
Eligibility Criteria
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Inclusion Criteria
* Age above or equal to 18 years at the time of signing informed consent.
* BMI greater than or equal to 30.0 kilograms per square meter (kg/m\^2).
* Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
* History of at least one self-reported unsuccessful dietary effort to lose body weight.
* HbA1c 7.0-10.0 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by central laboratory at screening.
Exclusion Criteria
* Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m\^2) (less than 45 mL/min/1.73 m\^2 in participants treated with Sodium-glucose Cotransporter-2 \[SGLT2i\]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Univ of Alabama Birmingham
Birmingham, Alabama, United States
John Muir Physicians Network
Concord, California, United States
Velocity Clinical Research Westlake
Los Angeles, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
New West Physicians PC
Golden, Colorado, United States
ARS- Deland CRU
DeLand, Florida, United States
Jacksonville Ctr for Clin Res
Jacksonville, Florida, United States
Florida Inst For Clin Res LLC
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
University of North Carolina
Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Amarillo Med Spec LLP
Amarillo, Texas, United States
Elligo Clin Res Centre
Austin, Texas, United States
Velocity Clin Res, Dallas
Dallas, Texas, United States
UT Southwestern Medical Center - Lingvay
Dallas, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
DCOL Ctr for Clin Res
Longview, Texas, United States
Sugar Lakes Family Practice PA
Sugar Land, Texas, United States
National Clin Res Inc.
Richmond, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
"MHAT-Blagoevgrad", Department of Internal Diseases
Blagoevgrad, , Bulgaria
IPSOMC - Dr. Georgi Marinov
Burgas, , Bulgaria
"Medical Center Viva Feniks" Ood
Dobrich, , Bulgaria
UMHAT Pulmed, Department of endocrinology
Pazardzhik, , Bulgaria
'MHAT Sveta Karidad' EAD
Plovdiv, , Bulgaria
'MHAT Hadzhi Dimitar' OOD
Sliven, , Bulgaria
DCC VII - Sofia EOOD, Endocrinology
Sofia, , Bulgaria
"UMHAT- Prof. dr. Stoyan Kirkovich"
Stara Zagora, , Bulgaria
"MHAT "Sveti Panteleimon" - Yambol" AD
Yambol, , Bulgaria
Ocean West Research Clinic
Surrey, British Columbia, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Wharton Med Clin Trials
Hamilton, Ontario, Canada
Milestone Research
London, Ontario, Canada
Lausmed Kft.
Baja, Bács-Kiskun county, Hungary
Belinus Bt.
Debrecen, Hajdú-Bihar, Hungary
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, , Hungary
Bajcsy-Zsilinszky Kórház
Budapest, , Hungary
MED-TIMA Kft.
Budapest, , Hungary
Fejér Megyei Szent György Oktatókórház
Székesfehérvár, , Hungary
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, Poland
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, Poland
NZOZ "CenterMed Lublin" Sp. z o.o.
Lublin, Lublin Voivodeship, Poland
Kresmed Sp. z o. o.
Bialystok, Podlaskie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
Katowice, , Poland
NBR Polska Tomasz Klodawski
Warsaw, , Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, , Poland
Unidade Local De Saude De Matosinhos E.P.E.
Senhora Da Hora, Matosinhos, Matosinhos, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, , Portugal
Unidade Local de Saude de Sao Joao E.P.E
Porto, , Portugal
DIADA s.r.o.
Bardejov, , Slovakia
DIADA, s.r.o.
Bardejov, , Slovakia
Diab - Int, s.r.o.
Bytča, , Slovakia
ENDOMED, s.r.o.
Košice, , Slovakia
MED-DIA CENTRUM s.r.o.
Považská Bystrica, , Slovakia
DIABETOL, s.r.o.
Prešov, , Slovakia
Phoenix Pharma
Port Elizabeth, Eastern Cape, South Africa
Medi-Clinic Bloemfontein
Bloemfontein, Free State, South Africa
Deepak Lakha
Johannesburg, Gauteng, South Africa
Hemant Makan
Johannesburg, Gauteng, South Africa
Wits Bara Clinical Trial Site
Johannesburg, Gauteng, South Africa
Maxwell Centre
Durban, KwaZulu-Natal, South Africa
Dr N.K. Gounden Medical Centre
Durban, KwaZulu-Natal, South Africa
Lenmed Shifa Private Hospital
Durban, KwaZulu-Natal, South Africa
Dr T Padayachee
eMkhomazi, KwaZulu-Natal, South Africa
Countries
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References
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Lingvay I, Bergenheim SJ, Buse JB, Freitas P, Garvey WT, Harder-Lauridsen NM, Rosenstock J, Sahu K, Wharton S; STEP UP T2D trial group. Once-weekly semaglutide 7.2 mg in adults with obesity and type 2 diabetes (STEP UP T2D): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):935-948. doi: 10.1016/S2213-8587(25)00225-6. Epub 2025 Sep 14.
Other Identifiers
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2022-002235-60
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1279-0359
Identifier Type: OTHER
Identifier Source: secondary_id
NN9536-7545
Identifier Type: -
Identifier Source: org_study_id
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