A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

NCT05486065 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: NN9535-4984U1111-1271-92092022-000882-41
• Study Type: interventional
• Target: 245
• Locations: 5 countries
• Sites: 130

Brief Summary

This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide \[2 milligrams (mg), 8 mg, or 16 mg\] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Haemoglobin (HbA1c)

  Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented.

  Baseline (week 0) and End of treatment (week 40)

Secondary Outcomes (3)

• Change in Body Weight

  Baseline (week 0) and End of treatment (week 40)

• Number of Treatment-emergent Adverse Events (TEAEs)

  From baseline (week 0) up to end of study (week 49)

• Number of Treatment-emergent Severe Hypoglycaemic Episodes

  From baseline (week 0) up to end of study (week 49)

Study Arms (6)

Semaglutide 2 mg

EXPERIMENTAL

Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.

Drug: Semaglutide

Semaglutide placebo 2 mg

PLACEBO COMPARATOR

Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.

Drug: Placebo

Semaglutide 8 mg

EXPERIMENTAL

Participants will receive once-weekly semaglutide 8 mg s.c. injection.

Drug: Semaglutide

Semaglutide placebo 8 mg

PLACEBO COMPARATOR

Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.

Drug: Placebo

Semaglutide 16 mg

EXPERIMENTAL

Participants will receive once-weekly semaglutide 16 mg s.c. injection.

Drug: Semaglutide

Semaglutide placebo 16 mg

PLACEBO COMPARATOR

Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.

Drug: Placebo

Interventions

Semaglutide DRUG

Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.

Semaglutide 16 mg; Semaglutide 2 mg; Semaglutide 8 mg

Placebo DRUG

Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.

Semaglutide placebo 16 mg; Semaglutide placebo 2 mg; Semaglutide placebo 8 mg

Eligibility Criteria

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

You may qualify if:

• Male or female.
• Aged 18-64 years (both inclusive) at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.
• Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) \[53 - 91 millimoles per mole (mmol/mol)\] (both inclusive).
• Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m\^2).
• Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.

You may not qualify if:

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
• Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (\<) 30 milliliters per minute (mL/min)/1.73 meter square (m\^2) at screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (130)

Univ of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Velocity Clinical Res-Banning

Banning, California, 92220, United States

Location

Velocity Clin Res-Chula Vista

Chula Vista, California, 91911, United States

Location

Southern California Res Ctr

Coronado, California, 92118, United States

Location

Cedars-Sinai Medical Group

Encino, California, 91436, United States

Location

Velocity Clin Res Gardena

Gardena, California, 90247, United States

Location

Nat Res Inst Huntington Park

Huntington Park, California, 90255, United States

Location

Scripps Whittier Diabetes Inst

La Jolla, California, 92037, United States

Location

First Valley Med Grp Lancaster

Lancaster, California, 93534, United States

Location

Velocity Clin Res Los Angeles

Los Angeles, California, 90017, United States

Location

Diabetes Assoc. Med Group

Orange, California, 92868, United States

Location

Western University of Health Sciences

Pomona, California, 91766, United States

Location

San Diego Family Care_San Diego

San Diego, California, 92111, United States

Location

Mills-Peninsula Hlth Services

San Mateo, California, 94401, United States

Location

Encompass Clinical Research_Spring Valley

Spring Valley, California, 91978, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Optumcare Clinical Trials,LLC-Golden

Colorado Springs, Colorado, 80906, United States

Location

Innovative Research of W FL

Clearwater, Florida, 33756, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

Alliance for Multispec Res

Coral Gables, Florida, 33134, United States

Location

University Clin Res-Deland

DeLand, Florida, 32720, United States

Location

Northeast Research Institute

Fleming Island, Florida, 32003, United States

Location

Indago Research & Health Center Inc.

Hialeah, Florida, 33012, United States

Location

Northeast Res Inst. Inc.

Jacksonville, Florida, 32204, United States

Location

New Life Medical

Miami, Florida, 33130, United States

Location

Genesis Research Center, LLC

Miami, Florida, 33155, United States

Location

Suncoast Clinical Research, Inc.

Miami, Florida, 33173, United States

Location

Reyes Clinical Research, Inc

Miami, Florida, 33174, United States

Location

San Marcus Res Clin Miami Lakes

Miami Lakes, Florida, 33014, United States

Location

Clinical Neuroscience Solution

Orlando, Florida, 32801, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

Location

Family Clinical Trials

Pembroke Pines, Florida, 33026, United States

Location

Northeast Research Institute

Saint Augustine, Florida, 32080, United States

Location

St Johns Center for Clin. Res

Saint Augustine, Florida, 32086, United States

Location

Appalachian Clinical Res LLC

Adairsville, Georgia, 30103, United States

Location

Urban Family Practice Assoc

Marietta, Georgia, 30067, United States

Location

Herman Clinical Research LLC

Suwanee, Georgia, 30024, United States

Location

Rocky Mt Clin Res, LLC

Idaho Falls, Idaho, 83404-7596, United States

Location

Velocity Clinical Res Boise

Meridian, Idaho, 83642, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States

Location

West Broadway Clinic

Council Bluffs, Iowa, 51501, United States

Location

Iowa Diab & Endo Res Center

West Des Moines, Iowa, 50266, United States

Location

Cotton O'Neil Diab & Endo Ctr

Topeka, Kansas, 66606, United States

Location

The Research Group of Lexington LLC

Lexington, Kentucky, 40503, United States

Location

Norton Healthcare Research Office

Louisville, Kentucky, 40218, United States

Location

Barnum Medical Research Inc.

Natchitoches, Louisiana, 71457, United States

Location

MedStar Community Clin Res Ctr

Hyattsville, Maryland, 20782, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Endo And Metab Cons

Rockville, Maryland, 20852, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115-5804, United States

Location

Aa Mrc Llc

Flint, Michigan, 48504, United States

Location

Elite Research Center

Flint, Michigan, 48532, United States

Location

Arcturus HC PLC Troy Med Res

Troy, Michigan, 48098, United States

Location

Arcturus Healthcare, PLC

Troy, Michigan, 48098, United States

Location

StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States

Location

Premier Research Inc.

Trenton, New Jersey, 08611, United States

Location

AMC Community Endocrinology

Albany, New York, 12203, United States

Location

Mid Hudson Med Res-New Windsor

New Windsor, New York, 12553, United States

Location

Northport VA Med Ctr Northport

Northport, New York, 11768, United States

Location

Southgate Medical Group, LLP

West Seneca, New York, 14224, United States

Location

UNC Eastowne Clinical Research Unit

Chapel Hill, North Carolina, 27514, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Providence Health Partners Ctr

Dayton, Ohio, 45439, United States

Location

Advanced Med Res Maumee

Maumee, Ohio, 43537, United States

Location

Velocity Clin Res Grants Pass

Grants Pass, Oregon, 97527, United States

Location

Velocity Clinical Res Medford

Medford, Oregon, 97504, United States

Location

Lycoming Internal Medicine, Inc.

Jersey Shore, Pennsylvania, 17740, United States

Location

Thomas Jefferson Univ Di Rsrch Ctr

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

CORE - Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Tower Health

West Reading, Pennsylvania, 19611, United States

Location

Velocity Clinical Research Columbia

Columbia, South Carolina, 29204, United States

Location

Velocity Clinical Research Greenville

Greenville, South Carolina, 29615, United States

Location

Coastal Carolina Res Ctr

Mt. Pleasant, South Carolina, 29464, United States

Location

Trial Management Associates

Myrtle Beach, South Carolina, 29572, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

Velocity Clinical Research Union

Union, South Carolina, 29379, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37404, United States

Location

Murphy Research Center

Humboldt, Tennessee, 38343, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

Amarillo Med Spec LLP

Amarillo, Texas, 79106, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Briggs Clinical Research, LLC

San Antonio, Texas, 78224, United States

Location

VIP Trials

San Antonio, Texas, 78230, United States

Location

DCT-Stone Oak

San Antonio, Texas, 78258, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Dwayne O. Williams, M.D., P.A.

Sugar Land, Texas, 77479, United States

Location

Hillcrest Family Health Center

Waco, Texas, 76708, United States

Location

Nova Health Management & Research Group, PC

Herndon, Virginia, 20171, United States

Location

Dominion Medical Associates

Richmond, Virginia, 23219, United States

Location

Amherst Family Practice P.C.

Winchester, Virginia, 22601, United States

Location

Velocity Clinical Research Spokane

Spokane, Washington, 99203, United States

Location

St. Vincent Hosp-Prevea Health

Green Bay, Wisconsin, 54303, United States

Location

Clinical Investigation Spec. Kenosha

Kenosha, Wisconsin, 53144, United States

Location

University Hospital of Athens ATTIKON

Athens, Attica, 12462, Greece

Location

Iatriko Psychicou Private Clinic

Athens, 115 25, Greece

Location

Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter

Athens, 11527, Greece

Location

Alexandra General Hospital, Therapeutic Clinic

Athens, 11528, Greece

Location

Iatriko Athinon (Athens Medical Canter)

Athens, 15125, Greece

Location

Iatriko Athinon 'Palaiou Falirou'

Athens, 17562, Greece

Location

Univ Gen Hospital Larisa

Larissa, 41110, Greece

Location

General Hospital of Thessaloniki 'G. Gennimatas

Thessaloniki, 54635, Greece

Location

'Ippokrateio' General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes

Thessaloniki, 54645, Greece

Location

"Thermi" Private Hosital

Thessaloniki, 57001, Greece

Location

General Hospital of Thessaloniki "G.Papanikolaou"

Thessaloniki, 57010, Greece

Location

Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Szeged, Csongrád-Csanád, 6725, Hungary

Location

Komáromi Selye János Kórház

Komárom, Komárom-Esztergom, 2900, Hungary

Location

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, 1032, Hungary

Location

ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

Budapest, 1089, Hungary

Location

Bajcsy-Zsilinszky Kórház

Budapest, 1106, Hungary

Location

MH Egészségügyi Központ

Budapest, 1134, Hungary

Location

Kanizsai Dorottya Kórház

Nagykanizsa, 8800, Hungary

Location

Vas Vármegyei Markusovszky Egyetemi Oktatókórház

Szombathely, 9700, Hungary

Location

NBR Polska

Warsaw, Masovian Voivodeship, 00-465, Poland

Location

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

Bialystok, Podlaskie Voivodeship, 15-435, Poland

Location

NZOZ Vita-Diabetica Malgorzata Buraczyk

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Pro Familia Altera Sp. z o.o.

Katowice, Silesian Voivodeship, 40-648, Poland

Location

Ko-Med Centra Kliniczne Staszow

Staszów, 28-200, Poland

Location

NBR Polska Tomasz Klodawski

Warsaw, 00-710, Poland

Location

Clinmedica Research sp. z o.o.

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

Velocity Nova Sp. z o.o.

Staszów, Świętokrzyskie Voivodeship, 28-200, Poland

Location

Manati Ctr For Clin Research

Manatí, 00674, Puerto Rico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 3, 2022
• Study Start: August 8, 2022
• Primary Completion: October 12, 2023
• Study Completion: December 13, 2023
• Last Updated: December 12, 2025
• Results First Posted: November 5, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); PL (8); US (101); HU (8); GR (12)