A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight

NCT05649137 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: NN9536-75452022-002235-60U1111-1279-0359
• Study Type: interventional
• Target: 512
• Locations: 8 countries
• Sites: 76

Brief Summary

This study will look at how much weight participants will lose and how much blood sugar control they achieve 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. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years

Conditions

Obesity; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Relative Change in Body Weight

  Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.

  Baseline (week 0), End of treatment (week 72)

• Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)

  Number of participants who achieve body weight reduction \>=5% is presented. Yes defines participants who achieved body weight reduction \>= 5% and No defines participants who did not achieve body weight reduction \>=5%.

  At week 72

Secondary Outcomes (34)

• Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)

  At week 72

• Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)

  At week 72

• Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)

  At week 72

• Change in Waist Circumference

  Baseline (week 0), End of treatment (week 72)

• Change in Glycated Haemoglobin (HbA1c)

  Baseline (week 0), End of treatment (week 72)

Study Arms (3)

Semaglutide 7.2 mg

EXPERIMENTAL

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.

Drug: Semaglutide

Semaglutide 2.4 mg

EXPERIMENTAL

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.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.

Drug: Placebo

Interventions

Semaglutide DRUG

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 7.2 mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• 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.

You may not qualify if:

• A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds \[lbs\]) 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.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (76)

Univ of Alabama Birmingham

Birmingham, Alabama, 35222, United States

Location

Chambliss Clinical Trials, LLC

Montgomery, Alabama, 36106, United States

Location

John Muir Physicians Network

Concord, California, 94520, United States

Location

Velocity Clinical Research Westlake

Los Angeles, California, 90057, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

New West Physicians PC

Golden, Colorado, 80401, United States

Location

ARS- Deland CRU

DeLand, Florida, 32720, United States

Location

Jacksonville Ctr for Clin Res

Jacksonville, Florida, 32216, United States

Location

Florida Inst For Clin Res LLC

Orlando, Florida, 32825, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

Location

Hope Clin Res & Wellness

Conyers, Georgia, 30094, United States

Location

AMC Community Endocrinology

Albany, New York, 12203, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Amarillo Med Spec LLP

Amarillo, Texas, 79106, United States

Location

Elligo Clin Res Centre

Austin, Texas, 78704, United States

Location

Velocity Clin Res, Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Medical Center - Lingvay

Dallas, Texas, 75390, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

DCOL Ctr for Clin Res

Longview, Texas, 75605, United States

Location

Sugar Lakes Family Practice PA

Sugar Land, Texas, 77479, United States

Location

National Clin Res Inc.

Richmond, Virginia, 23294, United States

Location

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

Location

MHAT - Blagoevgrad AD, Department of Internal Diseases

Blagoevgrad, 2700, Bulgaria

Location

IPSOMC - Dr. Georgi Marinov

Burgas, 8000, Bulgaria

Location

Medical Center Viva Feniks OOD

Dobrich, 9300, Bulgaria

Location

UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases

Pazardzhik, 4400, Bulgaria

Location

MHAT Sveta Karidad EAD

Plovdiv, 4004, Bulgaria

Location

MHAT Hadzhi Dimitar OOD

Sliven, 8800, Bulgaria

Location

DCC VII - Sofia EOOD, Endocrinology

Sofia, 1233, Bulgaria

Location

UMHAT Prof. Dr. Stoyan Kirkovich AD

Stara Zagora, 6003, Bulgaria

Location

MHAT Sveti Panteleimon - Yambol AD

Yambol, 8600, Bulgaria

Location

Ocean West Research Clinic

Surrey, British Columbia, V3Z 2N6, Canada

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, L8L 5G4, Canada

Location

Wharton Medical Clinic Clinical Trials (Hamilton)

Hamilton, Ontario, L8L 5G8, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

Lausmed Kft.

Baja, Bács-Kiskun county, 6500, Hungary

Location

Belinus Bt.

Debrecen, Hajdú-Bihar, 4025, Hungary

Location

Borbánya Praxis E.Ü. Kft.

Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary

Location

ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

Budapest, 1089, Hungary

Location

Bajcsy-Zsilinszky Kórház

Budapest, 1106, Hungary

Location

MED-TIMA Kft.

Budapest, 1132, Hungary

Location

Fejér Megyei Szent György Oktatókórház

Székesfehérvár, 8000, Hungary

Location

Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET

Krakow, Lesser Poland Voivodeship, 31-261, Poland

Location

NZOZ Przychodnia Specjalistyczna Medica

Lublin, Lubelski, 20-538, Poland

Location

NZOZ "CenterMed Lublin" Sp. z o.o.

Lublin, Lublin Voivodeship, 20-044, Poland

Location

Kresmed Sp. z o. o.

Bialystok, Podlaskie Voivodeship, 15-481, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Uniwersyteckie Centrum Kliniczne SUM w Katowicach

Katowice, 40-752, Poland

Location

NBR Polska Tomasz Klodawski

Warsaw, 00-710, Poland

Location

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, 02-507, Poland

Location

ULS De Matosinhos E.P.E.- Hospital Pedro Hispano

Senhora Da Hora, Matosinhos, Matosinhos, 4464-513, Portugal

Location

APDP - Associação Protectora dos Diabéticos de Portugal

Lisbon, 1250-230, Portugal

Location

Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz

Lisbon, 1349-019, Portugal

Location

Hospital da Luz Lisboa, S.A.

Lisbon, 1500-650, Portugal

Location

ULS De São João, E.P.E. - Hospital de São João

Porto, 4200-319, Portugal

Location

Hospital da Luz Arrabida, S.A.

Vila Nova de Gaia, 4400-346, Portugal

Location

DIADA s.r.o.

Bardejov, 08501, Slovakia

Location

DIADA, s.r.o.

Bardejov, 08501, Slovakia

Location

Diab - Int, s.r.o.

Bytča, 014 01, Slovakia

Location

ENDOMED, s.r.o.

Košice, 04013, Slovakia

Location

MED-DIA CENTRUM s.r.o.

Považská Bystrica, 01701, Slovakia

Location

DIABETOL, s.r.o.

Prešov, 080 01, Slovakia

Location

Phoenix Pharma

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

Medi-Clinic Bloemfontein

Bloemfontein, Free State, 9301, South Africa

Location

Soweto Clinical Trial Centre

Johannesburg, Gauteng, 1818, South Africa

Location

Deepak Lakha

Johannesburg, Gauteng, 1820, South Africa

Location

Hemant Makan

Johannesburg, Gauteng, 1827, South Africa

Location

Wits Bara Clinical Trial Site

Johannesburg, Gauteng, 2013, South Africa

Location

Maxwell Centre

Durban, KwaZulu-Natal, 4001, South Africa

Location

Precise Clinical Solutions (Pty) Ltd

Durban, KwaZulu-Natal, 4092, South Africa

Location

Dr N.K. Gounden Medical Centre

Durban, KwaZulu-Natal, 4093, South Africa

Location

Lenmed Shifa Private Hospital

Durban, KwaZulu-Natal, 4901, South Africa

Location

Dr T Padayachee

eMkhomazi, KwaZulu-Natal, 4170, South Africa

Location

Related Publications (1)

• 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.

  PMID: 40961953 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: January 4, 2023
• Primary Completion: October 28, 2024
• Study Completion: December 13, 2024
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

HU (7); CA (6); PT (6); SL (6); ZA (11); US (23); BU (9); PL (8)