Overweight or ObesitySHINENCT06087822
Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®
A study testing IMD SiPore21® in people with Overweight or Obesity, run by Sigrid Therapeutics AB at 27 sites in 3 countries.
Trial summary
The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia. The investigation will be performed to establish clinical evidence regarding the performance and safety of the IMD and is aiming at… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- IMD SiPore21®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 5 Oct 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18-70 years old
- HbA1c level ≥42 to 58 mmol/mol (≥6 to 7.5% - according to Diabetes Control and Complications Trial [DCCT, 1987]) at V1 For Poland only: HbA1c level ≥42 to 53 mmol/mol (≥6 to 7% - according to the Official Journal of the Diabetes Poland, 2023 Vol. 3 Issue 1) at V1
- Body mass index (BMI) >25 kg/m2 and 40 kg/m2
- Regular intake of 3 main meals (self-reported)
- Readiness and ability to:
- use the study treatment as recommended and attend all scheduled visits
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- comply with all further study procedures
- Readiness to maintain the current diet and level of physical activity during the study
- Readiness not to participate in another clinical study during this study
- Women of childbearing potential: commitment to use medically recognized contraception methods during the treatment period
- Written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study
Who cannot join
- Known allergy or hypersensitivity to the components of the IMD or placebo (self-reported)
- Type 1 diabetes (T1D)/Latent Autoimmune Diabetes in Adult or secondary diabetes (self-reported)
- Uncontrolled hypertension (regularly >179/109 mmHg [self-reported] and as per investigator's judgement based on screening procedures at V1)
- History (self-reported) of myocardial infarction or stroke 6 months prior to V1
- Clinically relevant abnormal electrocardiogram (ECG) at V1
- History (<3 years prior to V1) or presence (self-reported) of:
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- exocrine pancreatic insufficiency, chronic pancreatitis
- chronic inflammatory bowel disease, celiac disease
- diverticulosis (usually affecting the large intestine), adhesions, chronic constipation
- State after pancreatic head resection with the need for additional intake of pancreatic enzymes (self-reported)
- Major surgery of esophagus, stomach, intestine including colon which took place <3 years prior to V1, or >3 years prior to V1 in case of related current clinical symptoms (self-reported)
- Clinically significant deviation, based on investigators judgment, in blood laboratory values at V1 of blood status (hemoglobin, erythrocytes, platelets, leucocytes, reticulocytes), kidney parameters (creatinine, cystatin C and estimated glomerular filtration rate), thyroid hormone status: thyroid-stimulating hormone (TSH)
- Deviation in blood laboratory values at V1 of liver parameters (aspartate aminotransferase [ASAT], alanine transaminase [ALAT], alkaline phosphatase and γ-glutamyl transpeptidase [Gamma-GT]) that is clinically significant based on investigators judgment
- Blood donation/other major blood loss or blood transfusion, that may interfere with the study as per investigator's judgment, within 56 days prior to V1 and any blood donation or transfusion during the study
- Previous or current metformin or other medical anti-diabetic treatment or blood glucose levels reducing/influencing treatment/supplementation within 30 days prior to V1 and during the study
- Current treatment/supplementation for weight management (e.g., fat binder/burner, carb blocker, satiety products) or known to influence weight (e.g., systemic corticosteroids)
- Medical conditions that require medications taken during meals
- Extreme diet form (e.g., ketogenic, very low carbohydrate) during the last 3 months prior to study
- Self-reported regular average consumption of >1 L/day total of sugary beverages (e.g., soft drinks, fruit juices, energy drinks) and/or >200 g/day total of food based on simple sugar(s) between meals (e.g., commercial candies, dried fruit)
- Pregnancy, lactation or active planning to achieve pregnancy
- History of or current abuse of drugs, alcohol or medication
- Any severe diseases/disorder (e.g., chronic kidney disease, neoplastic disease or psychiatric disorder) which may interfere with the compliance to the study procedures as per investigator's judgement
- Participation in another study during the last 30 days prior to V1
- Belonging to a vulnerable population, having any condition or other reason which in the opinion of the investigator would confound the conduct of the study or interpretation of the study results
- Relative of the investigator or an employee at the clinical study site and Sponsor
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
Poland11 sites
Klimed ul. Jana Pawła II 59 lok. 6U,
Bialystok, 15-704
RENEW Clinic ul. Gajowa 29,
Bialystok, 15-794
Klimed Bychawa ul. Piłsudskiego 28,
Bychawa, 23-100
Diab Serwis Popenda Spółka Jawna Józefa Ryszki 51,
Chorzów, 41-500
Centrum Nowoczesnych Terapii Dobry Lekarz plac Szczepański 3/II,
Krakow, 31-011
Amicare centrum medyczne Ul. Zgierska 249,
Lodz, 91-495
Clinical Best Solutions ul. Cicha 4/1,
Lublin, 20-078
KO-MED Centra Kliniczne Lublin II ul. K. Przerwy-Tetmajera 21, 20-362
Lublin, 20-362
Dom Lekarski Centrum Medyczne Outlet Park ul. Andrzeja Struga 42,
Szczecin, 70-784
MTZ Clinical Research Powered by Pratia ul. Gładka 22,
Warsaw, 02-172
Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ we Wrocławiu ul.Weigla 5,
Wroclaw, 50-981
Slovakia10 sites
Metabol KLINIK, s.r.o.Cukrová 3
Bratislava, 811 08
Metabolické centrum Dumbierska 32
Bratislava, 831 01
DIABEDA, s.r.o.Zdravotnícke stredisko, Tbiliska 6,
Bratislava - Rača, 831 06
Diversitas s.r.o., SNP 870/10
Hlohovec, 920 01
INTERN, s.r.o. L. Štúra 846/39
Ilava, 01901
Všeobecná ambulancia pre dospelých Nábrežná 3043/3
Levice, 934 05
SALUBER SK, s.r.o Piešťanská 1166/ 5,
Nové Mesto nad Váhom, 915 01
MEDIPA, s.r.o., internist Sládkovicova 2A
Piešťany, 921 01
Dr. Viliam Cibik, Pruské 293,
Pruské, 018 52
MUDr. Dagmar Žáková Súvoz 1
Trencín, 911 01
Romania6 sites
Neomed Strada Crișului nr. 1,
Brasov, 500283
Nicodiab Strada Polonă 92, Bl. 17 A+B
Bucharest, 010507
Spitalul Universitar de Urgenta Militar Central 'Dr Carol Davila' Calea Plevnei 134,
Bucharest, 010825
Fundatia Ana Aslan International Strada Vasile Pârvan, nr 12, ap 1, 010216,
Bucharest
RO03 MediPrax Centrum Strada Petru Maior 6-8
Cluj-Napoca, 400002
Clubul Sanatatii SRL Strada I. C. Brătianu 54B Cȃmpulung Muscel, Argeş
Mușcel, 115100
About this study
Official title: Randomized, Double-blinded, Placebo-controlled, Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21® in Obese or Overweight Subjects With Elevated Blood Glucose Levels
The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia. The investigation will be performed to establish clinical evidence regarding the performance and safety of the IMD and is aiming at evaluating the suitability of the IMD for the intended purpose and population.
Read the detailed description
The proposed investigation is set out to be a randomized, double blind, placebo-controlled, multicenter study according to MDR Article 62 to investigate performance and safety of the medical device SiPore21® in subjects with obesity or overweight and elevated blood glucose levels.
The aim of this clinical investigation is to evaluate the clinical performance of the IMD for blood glucose control and its clinical safety. The endpoints selected to evaluate the effects of the IMD are based on the state-of-the-art assessments of blood glucose control (ADA, 2022).
The main hypothesis is that treatment with SiPore21® for 12 weeks will reduce the HbA1c in obese or overweight subjects with elevated blood glucose levels. It is further hypothesized that treatment with SiPore21® for 12 weeks will result in a reduction in body weight and influence metabolic control parameters and lipid levels.
- Conditions
- Overweight or Obesity
- Being tested
- IMD SiPore21®
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMD SiPore21®Device
The intended use/purpose to improve blood glucose control, as measured by a reduction in HbA1c
| Study group | Role | What they receive |
|---|---|---|
| IMD SiPore21® | Experimental | IMD Class IIb Total daily dose: 3 stick packs (1 x 3 main meals) uration 12 weeks Receives: Device: IMD SiPore21® |
| Placebo Comparator | Placebo comparator | Placebo Total daily dose: 3 stick packs (1 x 3 main meals) duration 12 weeks Receives: Device: IMD SiPore21® |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c level
To evaluate if the IMD treatment leads to a greater reduction in HbA1c level (relative to baseline) in comparison to placebo, in obese or overweight subjects with elevated blood glucose levels.
Measured: Difference in changes in HbA1c levels from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.
Secondary outcomes (1)
Body weight
To evaluate if the IMD treatment leads to a greater reduction in body weight (relative to baseline) in comparison to placebo.
Measured: Difference in changes in body weight assessed on-site from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start5 Oct 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled, multicenter clinical investigation according to Medical Device Regulation article 62
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sigrid Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Klockare, Study director, Sigrid Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087822
- Sponsor's protocol ID
- SITH/001921
- Acronym
- SHINE
- Status last verified
- Dec 2024
- First submitted
- 11 Oct 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baek J, Ioannidou A, Borg ML, Robert-Nicoud G, Pietilainen KH, Rossner S, Johnston EV, Bengtsson T. Effect of engineered mesoporous silica particles with tailored pore size on glycaemic control in individuals with prediabetes or type 2 diabetes: a randomised, double-blind, placebo-controlled SHINE trial. EClinicalMedicine. 2026 Jul 2;97:104042. doi: 10.1016/j.eclinm.2026.104042. eCollection 2026 Jul.
PubMed 42433278
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blinded, Placebo-controlled, Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21® in Obese or Overweight Subjects With Elevated Blood Glucose Levels
- ClinicalTrials.gov ID
- NCT06087822
- Acronym / sponsor ID
- SHINE / SITH/001921
- Conditions
- Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Sigrid Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia. The investigation will be performed to establish clinical evidence regarding the performance and safety of the IMD and is aiming at evaluating the suitability of the IMD for the intended purpose and population.
Detailed description
The proposed investigation is set out to be a randomized, double blind, placebo-controlled, multicenter study according to MDR Article 62 to investigate performance and safety of the medical device SiPore21® in subjects with obesity or overweight and elevated blood glucose levels.
The aim of this clinical investigation is to evaluate the clinical performance of the IMD for blood glucose control and its clinical safety. The endpoints selected to evaluate the effects of the IMD are based on the state-of-the-art assessments of blood glucose control (ADA, 2022).
The main hypothesis is that treatment with SiPore21® for 12 weeks will reduce the HbA1c in obese or overweight subjects with elevated blood glucose levels. It is further hypothesized that treatment with SiPore21® for 12 weeks will result in a reduction in body weight and influence metabolic control parameters and lipid levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, multicenter clinical investigation according to Medical Device Regulation article 62
| Arm | Type | Receives |
|---|---|---|
| IMD SiPore21® | Experimental | Device: IMD SiPore21®IMD Class IIb Total daily dose: 3 stick packs (1 x 3 main meals) uration 12 weeks |
| Placebo Comparator | Placebo comparator | Device: IMD SiPore21®Placebo Total daily dose: 3 stick packs (1 x 3 main meals) duration 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female 18-70 years old
- HbA1c level ≥42 to 58 mmol/mol (≥6 to 7.5% - according to Diabetes Control and Complications Trial [DCCT, 1987]) at V1 For Poland only: HbA1c level ≥42 to 53 mmol/mol (≥6 to 7% - according to the Official Journal of the Diabetes Poland, 2023 Vol. 3 Issue 1) at V1
- Body mass index (BMI) >25 kg/m2 and 40 kg/m2
- Regular intake of 3 main meals (self-reported)
- Readiness and ability to:
Key exclusion criteria (25 listed)
- Known allergy or hypersensitivity to the components of the IMD or placebo (self-reported)
- Type 1 diabetes (T1D)/Latent Autoimmune Diabetes in Adult or secondary diabetes (self-reported)
- Uncontrolled hypertension (regularly >179/109 mmHg [self-reported] and as per investigator's judgement based on screening procedures at V1)
- History (self-reported) of myocardial infarction or stroke 6 months prior to V1
- Clinically relevant abnormal electrocardiogram (ECG) at V1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMD SiPore21®The intended use/purpose to improve blood glucose control, as measured by a reduction in HbA1c | Device | IMD SiPore21®, Placebo Comparator |
Primary outcome
HbA1c level
Time frame: Difference in changes in HbA1c levels from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.
To evaluate if the IMD treatment leads to a greater reduction in HbA1c level (relative to baseline) in comparison to placebo, in obese or overweight subjects with elevated blood glucose levels.
1 secondary outcome
Body weight
Time frame: Difference in changes in body weight assessed on-site from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 42433278Baek J, Ioannidou A, Borg ML, Robert-Nicoud G, Pietilainen KH, Rossner S, Johnston EV, Bengtsson T. Effect of engineered mesoporous silica particles with tailored pore size on glycaemic control in individuals with prediabetes or type 2 diabetes: a randomised, double-blind, placebo-controlled SHINE trial. EClinicalMedicine. 2026 Jul 2;97:104042. doi: 10.1016/j.eclinm.2026.104042. eCollection 2026 Jul.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Klockare study director
Sigrid Therapeutics
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMD SiPore21® in people with Overweight or Obesity, run by Sigrid Therapeutics AB at 27 sites in 3 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 11 inclusion and 25 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Poland, Slovakia, Romania. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HbA1c level (time frame: Difference in changes in HbA1c levels from V2 (baseline) to V4 (week 12) between IMD treatment group and placebo group.). 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 NCT06087822, which also lists 1 linked publication.
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 9 Dec 2024.