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DRUG16 trials

Sponsors

Aarhus University Hospital, Odense University Hospital, UZ Leuven, Bispebjerg Hospital, Steno Diabetes Center Copenhagen, Novo Nordisk A/S

Conditions

"double diabetes"Cardiovascular disorders: Hypertension and ObesityChronic kidney diseaseCraving for and use of chemsex-related drugsDiabetic foot ulcerHIV & ObesityIdiopathic Intracranial HypertensionMild cognitive impairment (MCI) or mild dementia

Phase 2

A randomised, controlled, parallel group, open-label trial evaluating the impact of treatment with the GLP-1 analogue semaglutide on weight loss in people living with HIV and obesity (SWIFT Study)

RecruitingCTIS2024-513168-24-00

University College DublinHIV & Obesity

Start: 2022-06-01Target: 80Updated: 2025-12-19

Does the glucagon-like peptide-1 receptor agonist semaglutide prevent deterioration of metabolic state in prediabetic or diabetic patients with schizophrenia treated with the antipsychotic compounds clozapine or olanzapine?

Not yet recruitingCTIS2024-518746-24-00

Psykiatrisk Center KobenhavnSchizophrenia

Target: 104Updated: 2024-11-04

The SEMAFOOT2 Pilot. Effect of semaglutide on healing of foot ulcers in type 2 diabetes patients. A Pilot study.

Not yet recruitingCTIS2023-504913-65-01

Bispebjerg HospitalDiabetic foot ulcer, Type 2 diabetes

Target: 100Updated: 2025-09-29

An open-label, single-center, non-controlled pilot clinical trial to assess the efficacy of weekly semaglutide in combination with regular counselling sessions to reduce craving and use of chemsex associated drugs (CoSem4Chemsex) study.

Not yet recruitingCTIS2025-524177-16-00

Institute Of Tropical MedicineCraving for and use of chemsex-related drugs

Target: 22Updated: 2026-02-12

Phase 3

Semaglutide for the treatment of glucose intolerance in women with prior gestational diabetes: a double blind RCT

RecruitingCTIS2022-502082-22-00

UZ Leuvenprediabetes

Start: 2023-09-14Target: 252Updated: 2025-11-19

A randomised double-blind placebo-controlled clinical study investigating the effects of semaglutide s.c. once-weekly versus placebo on central and peripheral inflammation in participants with Alzheimer’s disease.

CompletedCTIS2023-506825-13-00

Novo Nordisk A/Sboth of the Alzheimer’s type, Mild cognitive impairment (MCI) or mild dementia

Start: 2023-07-25End: 2025-06-26Target: 13Updated: 2025-02-17

Long-term effects of semaglutide on diabetic retinopathy in subjects with type 2 diabetes (FOCUS)

Active, not recruitingCTIS2023-506827-26-00

Novo Nordisk A/Sintensification of glycaemic control has also been associated with an initial worsening of diabetic retinopathy. This phenomenon is known as “early worsening”. The rationale of this trial is to establish the long-term effects of semaglutide on diabetic retinopathy in subjects with type 2 diabetes (T2D) using validated and standardised ophthalmic assessments. This trial is a post-authorisation safety study (PASS) conducted as a commitment to the European Medicines Agency, While it is well-established that long-term good glycaemic control will reduce the risk of diabetic retinopathy development and progression

Start: 2019-05-02Target: 589Updated: 2025-12-16

Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes

RecruitingCTIS2023-505794-32-04

Steno Diabetes Center CopenhagenType 1 diabetes

Start: 2024-07-05Target: 2000Updated: 2025-11-05

TOLEDDO: Effect of weekly GLP1 agonist treatment in "double diabetes": a randomized, open-label study

RecruitingCTIS2024-514906-30-00

Centre Hospitalier Universitaire De Dijon"double diabetes"

Start: 2024-10-14Target: 76Updated: 2025-12-09

Efficacy and safety of once-weekly semaglutide s.c. 2.0 mg as add-on to dose-reduced insulin glargine vs titrated insuline glargine in participants with type 2 diabetes and overweight

CompletedCTIS2024-510612-75-00

Novo Nordisk A/SParticipants with T2D and overweight

Start: 2022-08-31End: 2025-04-01Target: 398Updated: 2025-03-12

Semaglutide for people with obesity and resistant hypertension (SUPPORT): a pilot, randomized, parallel-group, integrated, multicentre clinical trial.

RecruitingCTIS2024-513958-29-00

Trinity College DublinCardiovascular disorders: Hypertension and Obesity

Start: 2025-04-24Target: 50Updated: 2025-11-10

Phase 4

Screening and intervention for subclinical coronary artery disease in patients with type 2 diabetes: THE STENO INTEN-CT STUDY

RecruitingCTIS2022-500143-21-01

Aarhus University Hospital, Odense University HospitalType 2 diabetes

Start: 2023-01-12Target: 7300Updated: 2024-09-20

Glucagone Like Peptide-1 Receptor (GLP-1R) Analogue Assisted Rapid Weight Loss Program as treatment of Idiopathic Intracranial Hypertension

CompletedCTIS2024-517120-19-02

RigshospitaletIdiopathic Intracranial Hypertension

Start: 2022-09-02End: 2025-10-28Target: 50Updated: 2025-06-04

Semaglutide and Finerenone for Kidney and Vascular Protection in CKD

RecruitingCTIS2025-522503-18-00

Region MidtjyllandChronic kidney disease

Start: 2025-10-27Target: 160Updated: 2025-09-09

Insulin resistance in type 2 diabetes: evaluating the pathogenic mechanisms of insulin resistance in the myocardium and the effects of the treatments with GLP-1RA and SGLT2i

WithdrawnCTIS2025-523374-17-01

Fundacio Hospital Universitari Vall D’Hebron Institut De RecercaType 2 diabetes

Target: 60Updated: 2025-12-23

Healing Diabetic Foot Ulcers with Semaglutide

Not yet recruitingCTIS2025-524738-24-00

Radboud universitair medisch centrum StichtingDiabetic foot ulcer

Target: 70Updated: 2026-03-30