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New semaglutide manufacturing process tested in diabetes patients

NCT ID NCT05478252

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a new way of making semaglutide works as well as the current version for controlling blood sugar in people with type 2 diabetes. 388 participants received weekly injections for about 8 months. The main goal was to compare changes in HbA1c levels between the two groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

388 people

The number who actually took part.

Started

Aug 2022

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed with type 2 diabetes (T2D) mellitus greater than equal to (≥) 180 days before screening. * Stable daily dose(s) ≥ 90 days prior to the day of screening of metformin ≥ 1500 milligrams (mg) or maximum tolerated or effective dose. * HbA1c of 7.0-10.5 percentage (%) \[53-91.3 millimoles per mole (mmol/mol)\] (both inclusive). Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * 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 and prior insulin treatment for gestational diabetes are allowed. * 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 randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 2

Contacts and locations

Locations

  • Adult Medicine of Lake County, Inc.

    Mt. Dora, Florida, 32757, United States

  • Advanced Med Res Maumee

    Maumee, Ohio, 43537, United States

  • Albert J Weisbrot

    Mason, Ohio, 45040-6815, United States

  • Alliance for Multispec Res

    Coral Gables, Florida, 33134, United States

  • Arcturus Healthcare, PLC.

    Troy, Michigan, 48098, United States

  • BTC of New Bedford, LLC

    New Bedford, Massachusetts, 02740, United States

  • Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j.

    Legnica, Lower Silesian Voivodeship, 59-220, Poland

  • Bluewater Clin Res Group,Inc

    Sarnia, Ontario, N7T 4X3, Canada

  • CVS Store Number: 01396

    Reston, Virginia, 20191-4327, United States

  • CVS Store Number: 05520

    Savannah, Georgia, 31405-6901, United States

  • CVS Store Number: 1537

    Richmond, Virginia, 23230-3005, United States

  • CVS Store Number: 7689

    Atlanta, Georgia, 30329-4015, United States

  • Canadian Centre for Research on Diabetes_Smiths Falls

    Smiths Falls, Ontario, K7A 4W8, Canada

  • Care Clinic

    Red Deer, Alberta, T4P 1K4, Canada

  • Centricity Res Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S3, Canada

  • Centricity Research Brampton

    Brampton, Ontario, L6S 0C6, Canada

  • Centricity Research Etobicoke

    Etobicoke, Ontario, M9R 4E1, Canada

  • Centricity Research New Minas

    New Minas, Nova Scotia, B4N 3R7, Canada

  • Centricity Research Ville St. Laurent VSL

    Saint-Laurent, Quebec, H4T 1Z9, Canada

  • Centrum Medyczne "Diabetika"

    Radom, 26-600, Poland

  • Clin Invest Spec, Inc

    Wauconda, Illinois, 60084, United States

  • Clinical Trial Systems (CTC)

    Pretoria, Gauteng, 0186, South Africa

  • DIA - SANTMART, s.r.o., Ambulancia diabetologie a poruch latkovej premeny a vyzivy

    Martin, 036 01, Slovakia

  • Diabetologicka ambulancia DIAMO s.r.o.

    Kežmarok, 06001, Slovakia

  • Diabetologicka ambulancia DIASTYLE s.r.o.

    Banská Bystrica, 97401, Slovakia

  • Diabetologicka ambulancia MUDr. Iveta Markova s.r.o

    Nitra, 94911, Slovakia

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • Dr A Amod

    Durban, KwaZulu-Natal, 4092, South Africa

  • Dr Pillay's Rooms

    Durban, KwaZulu-Natal, 4450, South Africa

  • Dwayne O. Williams, M.D., P.A.

    Sugar Land, Texas, 77479, United States

  • ETG Lublin

    Lublin, Lublin Voivodeship, 20-412, Poland

  • ETG Lublin

    Lublin, 20-412, Poland

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221, United States

  • Elite Research Center

    Flint, Michigan, 48532, United States

  • Elligo Clin Res Centre

    Austin, Texas, 78704, United States

  • Encompass Clinical Research_Spring Valley

    Spring Valley, California, 91978, United States

  • Encore Medical Research LLC

    Hollywood, Florida, 33024, United States

  • FDRC

    Costa Mesa, California, 92627, United States

  • FutureMeds Sp. z o.o.

    Wroclaw, 50-088, Poland

  • FutureMeds Sp. z o.o. Lodz

    Lodz, 91-363, Poland

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7, Canada

  • IVAMEDIC s.r.o.

    Košice, 040 11, Slovakia

  • Innovative Research of W FL

    Clearwater, Florida, 33756, United States

  • Innovative Research of W Florida Inc.

    Clearwater, Florida, 33756, United States

  • International Research Associates, LLC_Miami

    Miami, Florida, 33183, United States

  • Jongaie Research

    Pretoria, Gauteng, 0183, South Africa

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501, Poland

  • LCGK Research

    San Carlos, California, 94070, United States

  • LMC Clin Res Inc. Thornhill

    Concord, Ontario, L4K 4M2, Canada

  • LMC Clin Rsrch Inc. (Montreal)

    Montreal, Quebec, H4T 1Z9, Canada

  • LMC Endo Centres Ltd.(Bayview)

    Toronto, Ontario, M4G 3E8, Canada

  • LMC Manna Research

    Toronto, Ontario, M4G 3E8, Canada

  • M2M Badania Kliniczne

    Chorzów, 41-500, Poland

  • MD Medical Research

    Oxon Hill, Maryland, 20745, United States

  • MEDI-DIA s.r.o.

    Sabinov, 08301, Slovakia

  • MUDr. Jan Culak, s.r.o.

    Prievidza, 97101, Slovakia

  • Macoupin Research Group

    Gillespie, Illinois, 62033, United States

  • Manna Research Inc.

    Pointe-Claire, Quebec, H9R 4S3, Canada

  • Manna Research Quebec

    Lévis, Quebec, G6W 0M5, Canada

  • Martin Diagnostic Clinic

    Tomball, Texas, 77375, United States

  • Med Partners, Inc.

    Toluca Lake, California, 91602, United States

  • Medi-Clinic Bloemfontein

    Bloemfontein, Free State, 9301, South Africa

  • Medical Trust Clinics, Inc.

    Courtice, Ontario, L1E2J5, Canada

  • Milestone Research

    London, Ontario, N5W 6A2, Canada

  • Montana Medical Research

    Missoula, Montana, 59808, United States

  • Moriana Clinical Research

    Winnie Mandela, Free State, 9400, South Africa

  • N.Y. Family Practice Physicians

    Woodhaven, New York, 11421, United States

  • NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o.

    Gdansk, 80-858, Poland

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, 15-435, Poland

  • New Horizon Research Center

    Miami, Florida, 33165, United States

  • Nova Scotia Hlth Halifax

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z 2N6, Canada

  • Omega Research Consultants LLC

    Orlando, Florida, 32806, United States

  • Osteo Medic s.c. Artur Racewicz Jerzy Supronik

    Bialystok, 15-351, Poland

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warsaw, 02-507, Poland

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408, United States

  • Precise Clinical Solutions (Pty) Ltd

    Durban, KwaZulu-Natal, 4092, South Africa

  • Prime Medical Group, LLC

    Gilbert, Arizona, 85296, United States

  • Prinshof Medical Campus

    Pretoria, Gauteng, 0002, South Africa

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • Recherche GCP Research

    Montreal, Quebec, H1Y 3H5, Canada

  • Reyes Clinical Research, Inc

    Miami, Florida, 33175, United States

  • San Diego Family Care_San Diego

    San Diego, California, 92111, United States

  • Shop#1 Health Emporium

    Midrand, Gauteng, 1685, South Africa

  • Solaris Clinical Research

    Meridian, Idaho, 83646, United States

  • South Broward Research LLC

    Miramar, Florida, 33027, United States

  • South Broward Research LLC

    Pembroke Pines, Florida, 33027, United States

  • Southwest Clinical Trials

    Houston, Texas, 77081, United States

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303, United States

  • Sugar Lakes Family Practice PA

    Sugar Land, Texas, 77479, United States

  • Tapia Internal Medicine Clinic

    Paris, Texas, 75462, United States

  • The Research Group of Lexington LLC

    Lexington, Kentucky, 40503, United States

  • Tristar Clin Investigations, PC

    Philadelphia, Pennsylvania, 19114, United States

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302, United States

  • Univ Of Texas Hlth Science Cntr

    San Antonio, Texas, 78229, United States

  • University Clin Investigators

    Tustin, California, 92780, United States

  • VIP Trials

    San Antonio, Texas, 78230, United States

  • VIP Trials_San Antonio

    San Antonio, Texas, 78230, United States

  • Velocity Clin Res Los Angeles

    Los Angeles, California, 90017, United States

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230, United States

  • Velocity Clinical Research San Diego

    La Mesa, California, 91942, United States

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801-2028, United States

  • Wharton Med Clin Trials

    Hamilton, Ontario, L8L 5G8, Canada

  • Whiteville Medical Assoc, PA

    Whiteville, North Carolina, 28472, United States

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Other studies related to the condition(s) this trial covers.