NCT05533632CompletedPhase 4
Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes
Safety and Tolerability of Weekly Semaglutide 0.5 mg or 1.0 mg in Chilean Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 24 Sept 2025
Brief summary (registry, in English)
This study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (T2D) in Chile. Participants will get a once-weekly subcutaneous injection of semaglutide in doses decided by the study doctor's criteria, according to participant's personal needs. The study will last for about 24 weeks. Participants will have 4 clinic visits and 2 phone calls. Participants will have 3 laboratory tests during the study (blood and urine samples).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 6 Sept 2022
- Start date
- 25 Apr 2022
- Primary completion date
- 18 Jan 2024
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT05533632
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 104
- From 25 Apr 2022 to the primary completion date, 18 Jan 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in this study. Participation is defined as signed informed consent.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before the screening visit, except Coronavirus Disease 2019 (COVID-19) related trials (this is allowed).
- Treatment with any glucagon-like peptide-1 receptor agonists (GLP-1 RA) medication prior to the screening visit.
- Myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
- Use of systemic immunosuppressive treatment within 90 days prior to screening.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of ≤ 14 days.
- Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 12 months prior to screening.
Other illness
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
- History of pancreatitis (acute or chronic).
- Participants presently classified as being in New York Heart Association (NYHA) Class IV heart failure.
- History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
Lab values
- Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 milliliters/minute (mL/min)/1.73 meter square (m\^2) as per MDRD-4 (Modification of Diet in Renal Disease).
- Participants with alanine aminotransferase (ALT) \> 2.5 x upper normal limit (UNL).
Other
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator.
Who the study is looking for
- Participants diagnosed (clinically) with type 2 diabetes greater than equal to (≥) 90 days prior to the screening visit.
- Stable daily dose of Oral Antidiabetic Drug (OAD) and/or insulin treatment for ≥ 60 days prior to the screening visit.
- HbA1c 7.5-10% (59-86 millimoles per mole \[mmol/mol\]) (both inclusive) in Visit 1.
- Participants in which Ozempic is indicated according to approved local label.
- Fundoscopy/Fundus photography record less than equal to (≤) 12 months.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital San Juan de Dios_Santiago, Región Metropolitana Coordinator of this site? Confirm its status | Santiago, Región Metropolitana | Chile | Unknown status |
| Hospital Padre Hurtado Coordinator of this site? Confirm its status | Santiago, Región Metropolitana | Chile | Unknown status |
| Servicios Médicos Godoy Limitada Coordinator of this site? Confirm its status | Santiago, Región Metropolitana | Chile | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.