AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 2NCT05486065

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

A Phase 2 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 130 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
245 participants
Where
130 sitesin 5 countries
Study dates
8 Aug 2022to 13 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
  • 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.

Trial locations and contacts

130 sites in 5 countries.

130 sites in 5 countries

United States101 sites

  • Appalachian Clinical Res LLC

    Adairsville, Georgia, 30103

  • Biofortis Clinical Research

    Addison, Illinois, 60101

  • AMC Community Endocrinology

    Albany, New York, 12203

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106

  • Velocity Clinical Res-Banning

    Banning, California, 92220

  • Univ of Alabama Birmingham

    Birmingham, Alabama, 35294

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115-5804

  • UNC Eastowne Clinical Research Unit

    Chapel Hill, North Carolina, 27514

  • Chattanooga Medical Research, LLC

    Chattanooga, Tennessee, 37404

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Velocity Clin Res-Chula Vista

    Chula Vista, California, 91911

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

  • Innovative Research of W FL

    Clearwater, Florida, 33756

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Optumcare Clinical Trials,LLC-Golden

    Colorado Springs, Colorado, 80906

  • Velocity Clinical Research Columbia

    Columbia, South Carolina, 29204

  • Alliance for Multispec Res

    Coral Gables, Florida, 33134

  • Southern California Res Ctr

    Coronado, California, 92118

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • Providence Health Partners Ctr

    Dayton, Ohio, 45439

  • University Clin Res-Deland

    DeLand, Florida, 32720

  • Cedars-Sinai Medical Group

    Encino, California, 91436

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • Elite Research Center

    Flint, Michigan, 48532

  • Velocity Clin Res Gardena

    Gardena, California, 90247

  • Velocity Clin Res Grants Pass

    Grants Pass, Oregon, 97527

  • St. Vincent Hosp-Prevea Health

    Green Bay, Wisconsin, 54303

  • Velocity Clinical Research Greenville

    Greenville, South Carolina, 29615

  • Nova Health Management & Research Group, PC

    Herndon, Virginia, 20171

  • Indago Research & Health Center Inc.

    Hialeah, Florida, 33012

  • Murphy Research Center

    Humboldt, Tennessee, 38343

  • Nat Res Inst Huntington Park

    Huntington Park, California, 90255

  • MedStar Community Clin Res Ctr

    Hyattsville, Maryland, 20782

  • Rocky Mt Clin Res, LLC

    Idaho Falls, Idaho, 83404-7596

  • Northeast Res Inst. Inc.

    Jacksonville, Florida, 32204

  • Lycoming Internal Medicine, Inc.

    Jersey Shore, Pennsylvania, 17740

  • Clinical Investigation Spec. Kenosha

    Kenosha, Wisconsin, 53144

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

  • First Valley Med Grp Lancaster

    Lancaster, California, 93534

  • The Research Group of Lexington LLC

    Lexington, Kentucky, 40503

  • Velocity Clin Res Los Angeles

    Los Angeles, California, 90017

  • Norton Healthcare Research Office

    Louisville, Kentucky, 40218

  • Urban Family Practice Assoc

    Marietta, Georgia, 30067

  • Advanced Med Res Maumee

    Maumee, Ohio, 43537

  • Velocity Clinical Res Medford

    Medford, Oregon, 97504

  • Clinical Neuroscience Solutions

    Memphis, Tennessee, 38119

  • Velocity Clinical Res Boise

    Meridian, Idaho, 83642

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • New Life Medical

    Miami, Florida, 33130

  • Genesis Research Center, LLC

    Miami, Florida, 33155

  • Suncoast Clinical Research, Inc.

    Miami, Florida, 33173

  • Reyes Clinical Research, Inc

    Miami, Florida, 33174

  • San Marcus Res Clin Miami Lakes

    Miami Lakes, Florida, 33014

  • Coastal Carolina Res Ctr

    Mt. Pleasant, South Carolina, 29464

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572

  • Barnum Medical Research Inc.

    Natchitoches, Louisiana, 71457

  • Mid Hudson Med Res-New Windsor

    New Windsor, New York, 12553

  • Northport VA Med Ctr Northport

    Northport, New York, 11768

  • Diabetes Assoc. Med Group

    Orange, California, 92868

  • Clinical Neuroscience Solution

    Orlando, Florida, 32801

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Family Clinical Trials

    Pembroke Pines, Florida, 33026

  • Thomas Jefferson Univ Di Rsrch Ctr

    Philadelphia, Pennsylvania, 19107

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania, 19114

  • CORE - Temple University

    Philadelphia, Pennsylvania, 19140

  • Western University of Health Sciences

    Pomona, California, 91766

  • Dominion Medical Associates

    Richmond, Virginia, 23219

  • Endo And Metab Cons

    Rockville, Maryland, 20852

  • Northeast Research Institute

    Saint Augustine, Florida, 32080

  • St Johns Center for Clin. Res

    Saint Augustine, Florida, 32086

  • Quality Research Inc

    San Antonio, Texas, 78209

  • Briggs Clinical Research, LLC

    San Antonio, Texas, 78224

  • VIP Trials

    San Antonio, Texas, 78230

  • DCT-Stone Oak

    San Antonio, Texas, 78258

  • San Diego Family Care_San Diego

    San Diego, California, 92111

  • Mills-Peninsula Hlth Services

    San Mateo, California, 94401

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Velocity Clinical Research Spokane

    Spokane, Washington, 99203

  • Encompass Clinical Research_Spring Valley

    Spring Valley, California, 91978

  • Dwayne O. Williams, M.D., P.A.

    Sugar Land, Texas, 77479

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Herman Clinical Research LLC

    Suwanee, Georgia, 30024

  • Cotton O'Neil Diab & Endo Ctr

    Topeka, Kansas, 66606

  • Premier Research Inc.

    Trenton, New Jersey, 08611

  • Arcturus HC PLC Troy Med Res

    Troy, Michigan, 48098

  • Arcturus Healthcare, PLC

    Troy, Michigan, 48098

  • Velocity Clinical Research Union

    Union, South Carolina, 29379

  • Hillcrest Family Health Center

    Waco, Texas, 76708

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266

  • Tower Health

    West Reading, Pennsylvania, 19611

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

  • Accellacare

    Wilmington, North Carolina, 28401

  • Amherst Family Practice P.C.

    Winchester, Virginia, 22601

Other trials in United States

Greece12 sites

  • University Hospital of Athens ATTIKON

    Athens, Attica, 12462

  • Iatriko Psychicou Private Clinic

    Athens, 115 25

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

    Athens, 11527

  • Alexandra General Hospital, Therapeutic Clinic

    Athens, 11528

  • Iatriko Athinon (Athens Medical Canter)

    Athens, 15125

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, 17562

  • Univ Gen Hospital Larisa

    Larissa, 41110

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, 54635

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 54642

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

    Thessaloniki, 54645

  • "Thermi" Private Hosital

    Thessaloniki, 57001

  • General Hospital of Thessaloniki "G.Papanikolaou"

    Thessaloniki, 57010

Other trials in Greece

Hungary8 sites

  • Szent Margit Rendelőintézet Nonprofit Kft.

    Budapest, 1032

  • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1089

  • Bajcsy-Zsilinszky Kórház

    Budapest, 1106

  • MH Egészségügyi Központ

    Budapest, 1134

  • Komáromi Selye János Kórház

    Komárom, Komárom-Esztergom, 2900

  • Kanizsai Dorottya Kórház

    Nagykanizsa, 8800

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6725

  • Vas Vármegyei Markusovszky Egyetemi Oktatókórház

    Szombathely, 9700

Other trials in Hungary

Poland8 sites

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie Voivodeship, 15-435

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, Podlaskie Voivodeship, 15-879

  • Pro Familia Altera Sp. z o.o.

    Katowice, Silesian Voivodeship, 40-648

  • Clinmedica Research sp. z o.o.

    Skierniewice, Łódź Voivodeship, 96-100

  • Ko-Med Centra Kliniczne Staszow

    Staszów, 28-200

  • Velocity Nova Sp. z o.o.

    Staszów, Świętokrzyskie Voivodeship, 28-200

  • NBR Polska

    Warsaw, Masovian Voivodeship, 00-465

  • NBR Polska Tomasz Klodawski

    Warsaw, 00-710

Other trials in Poland

Puerto Rico1 site

  • Manati Ctr For Clin Research

    Manati, 00674

Other trials in Puerto Rico

About this study

Official title: Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study

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.

Being tested
Semaglutide, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

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

  • PlaceboDrug

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

Study groups in NCT05486065
Study groupRoleWhat they receive
Semaglutide 2 mgExperimentalParticipants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.
Receives: Drug: Semaglutide
Semaglutide placebo 2 mgPlacebo comparatorParticipants will receive once-weekly semaglutide placebo 2 mg s.c. injection.
Receives: Drug: Placebo
Semaglutide 8 mgExperimentalParticipants will receive once-weekly semaglutide 8 mg s.c. injection.
Receives: Drug: Semaglutide
Semaglutide placebo 8 mgPlacebo comparatorParticipants will receive once-weekly semaglutide placebo 8 mg s.c. injection.
Receives: Drug: Placebo
Semaglutide 16 mgExperimentalParticipants will receive once-weekly semaglutide 16 mg s.c. injection.
Receives: Drug: Semaglutide
Semaglutide placebo 16 mgPlacebo comparatorParticipants will receive once-weekly semaglutide placebo 16 mg s.c. injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycated Haemoglobin (HbA1c)

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

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

Secondary outcomes (3)

  1. Change in Body Weight

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

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

  2. Number of Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with use of investigational medicinal products (IMP), whether or not considered related to IMP. AE can therefore be any unfavourable \& unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with use of IMP. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period data are presented. On-treatment observation period is defined as time points from first drug date until first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until first date of end of study visit or date of death or date of withdrawal of informed consent or contact as defined by investigator for participants that are lost to follow up.

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

  3. Number of Treatment-emergent Severe Hypoglycaemic Episodes

    Number of treatment-emergent severe Hypoglycaemic episodes are presented. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. On treatment observation period data are presented. On-treatment oberservation period is defined as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until the first date of end of study visit or date of death or date of withdrawal of informed consent or date of last contact as defined by investigator for participants that are lost to follow up.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2022
  2. Study start8 Aug 2022
  3. Primary completion12 Oct 2023
  4. Study completion13 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05486065
Sponsor's protocol ID
NN9535-4984
Other IDs
U1111-1271-9209, 2022-000882-41
Status last verified
Nov 2025
First submitted
31 Jul 2022
Last updated
12 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 130 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in United States, Greece, Hungary, Poland, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (week 0) and End of treatment (week 40)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05486065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in