Current Clinical Trial Offerings | Enrolling Now | Upcoming Trials
Current Clinical Trial Offerings
The Clinical and Genetics Research in Diabetes and Cardiometabolic Disease program’s overarching goal is to improve the lives of people living with diabetes and cardiometabolic disease.
We conduct clinical trials in new therapeutics, diagnostic tools, and devices in:
- Type 1 diabetes
- Type 2 diabetes
- Monogenic diabetes, atypical diabetes, diabetes precision medicine
- Obesity (weight loss)
- NASH/NAFLD
- Cardiovascular Outcomes Trials
- Renal Outcomes Trials
Our team is comprised of a team of board-certified endocrinologists, certified diabetes educators, registered dieticians, research nurses & research coordinators. Our team collaborates with the University of Chicago Pritzker School of Medicine and Harvard School of Medicine.
Providers can refer patients to an enrolling trial or to our research volunteer database where they will be contacted about upcoming trials. Please refer to diabetesresearch@northshore.org or EPIC message Dr. Liana Billings or P Research Diabetes Pool.
ENROLLING NOW:
FABULINUS – A 52-week randomized, double-blind, placebo-controlled multi-center Phase 2b study with 52-week blinded extension assessing safety and efficacy of frexalimab, a CD40L-antagonist monoclonal antibody, for preservation of pancreatic beta-cell function in adults and adolescents with newly diagnosed type 1 diabetes on insulin therapy
Population: 18-35 years old, type 1 diabetes, initiated exogenous insulin replacement therapy < 90 days, random C-peptide levels ≥ 0.2 nmol/L, received T1D insulin hormone replacement therapy, positive for 1 T1D autoantibody
Design: Randomized, double-blind, frexalimab v. placebo
Duration: 2 years
Stipend: $25-300, up to $2,225 total
Contact: causton@northshore.org or 847.663.8524
COMBINE 4 – A 40 week study comparing the efficacy and safety of once weekly IcoSema and daily insulin glargine 100 units/mL in participants with type 2 diabetes inadequately controlled on oral anti-diabetic drugs
Population: T2D, A1c ≥ 8.0%, insulin naïve, BMI ≤ 40.0 kg/m2, currently treated with 1-3 OADs with stable daily doses
Design: Randomized, open label, parallel group comparing IcoSema vs. daily insulin glargine, with or without OADs
Duration: 11 months
Stipend: $25-75, up to $2,200 total
Contact: diabetesresearch@northshore.org or 847.663.8344
Eli Lilly Weight Loss – A Phase 2 Master Protocol for a Randomized, Controlled Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants with Obesity or Overweight
Population: 18-76 years old, stable body weight, BMI > 30 kg/m2 or BMI between 27 kg/m2 and 30 kg/m2 and have at least one of the following conditions: high blood pressure, dyslipidemia, heart disease, or obstructive sleep apnea
Design: Randomized, double-blind, controlled, LY3841136 vs placebo
Duration: 64 weeks
Stipend: TBD
Contact: diabetesresearch@northshore.org or 847.663.8344
IMPACT 2 – In-Home Study with MiniMed™ 780G Pump Automated Control in Type 2 - Evaluation of the AHCL System in Adults with Insulin-requiring Type 2 Diabetes
Population: T2D, A1c < 10.0%, TSH normal range, is on multiple daily injection (MDI) regimen (basal/bolus regimen with longacting insulin and rapid-acting analogs), defined as greater than or equal to 2 injections per day for at least 3 months
Design: Single arm with 2 phases using MiniMed™ 780G insulin pump with Guardian 4 Sensor and MiniMed™ 780G BLE 2.0 insulin pump with Disposable Sensor 5 (DS5)
Duration: 4.5 months
Stipend: $25-65, up to $770 total
Contact: diabetesresearch@northshore.org or 847.663.8344
SURPASS-SWITCH – A phase 4, Randomized, Open-label active-controlled study to investigate the efficacy and safety of switching from weekly dulaglutide to weekly tirzepatide in adults with type 2 diabetes
Population: Type 2 diabetes, on Trulicity 0.75 mg or 1.5 mg weekly, A1c 7.0-9.5
Design: Randomized open label, trulicity vs tirzepatide
Duration: 10 months, 12 clinic visits
Stipend: $28.00+/hour
Contact: diabetesresearch@northshore.org or 847.663.8344
REDEFINE3 – The cardiovascular safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with obesity and established cardiovascular disease
Population: History of obesity and MI, CVA or PAD, with or without type 2 diabetes
Design: Randomized double blinded, CagriSema vs. placebo
Duration: 3 years, 22 clinic visits
Stipend: $75/clinic visit, up to $1650 total
Contact: diabetesresearch@northshore.org or 847.663.8344
ACHIEVE 4 – A Phase 3, Open-Label Study of Once Daily LY3502970 Compared with Insulin Glargine in Adult Participants with Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
Population: Type 2 diabetes w/ A1c ≥ 7.0, on any combination of metformin/sulfonylurea/SGLT2i, cardiovascular risk factor/eGFR <60
Design: Randomized double blinded, oral GLP-1 LY3502970 vs lantus
Duration: ~2 years, 8 clinic visits, 7 phone visits
Stipend: TBD
Contact: diabetesresearch@northshore.org or 847.663.8344
REIMAGINE 2 – Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s.c. in doses 2.4/2.4 mg and 1.0/1.0 mg once weekly versus semaglutide 2.4 mg and 1.0 mg, cagrilintide 2.4 mg and placebo in participants with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor
Population: T2D, A1c 7.0-10.5%, BMI ≥ 25 kg/m2, stable daily dose ≥ 90 days before screening of antidiabetic drugs: metformin w/ or w/o SGLT2 inhibitor
Design: Randomized, double-blinded, CagriSema vs semaglutide vs cagrilintide vs placebo
Duration: 78 weeks
Stipend: $25-75 per visit, up to $1,625 total
Contact: diabetesresearch@northshore.org or 847.663.8344
REIMAGINE 4 – Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. once weekly versus tirzepatide 15 mg s.c. once weekly in participants with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor
Population: T2D, A1C 7.0-10.5%, Stable daily dose ≥ 90 days before screening of antidiabetic drugs: metformin w/ or w/o SGLT2 inhibitor, BMI ≥ 30 kg/m2
Design: Randomized, double-blind, CagriSema vs tirzepatide
Duration: 77 weeks
Stipend: $25-75 per visit, up to $1,300 total
Contact: diabetesresearch@northshore.org or 847.663.8344
UPCOMING TRIALS:
ZENITH High Proteinuria – A Phase III Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants with Chronic Kidney Disease and High Proteinuria
Population: CKD, eGFR ≥ 20 and < 90 mL/min/1.73m2 AND UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113 mg/mmoL), on RAASi (ACEi or ARB) therapy stable for at least 4 weeks.
Design: Randomized, double-blind, Zibotentan/Dapagliflozin vs. Dapagliflozin alone
Duration: 2 years
Stipend: TBD
Contact: jpazol@northshore.org or 847.663.8348
ReCET – A Multicenter, Randomized, Double-blind, Sham-controlled study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals with Type II Diabetes
Population: T2DM, inadequately controlled on non-insulin glucose-lowering medications, 22-70 years of age, A1C 7.5%-10.5%, BMI 27-40, on 2-4 non-insulin glucose lowering medications
Design: Randomized, double-blind, sham-controlled. Sham control arm patients can receive the ReCET procedure after conclusion of the study.
Duration: 12 months
Stipend: TBD
Contact: lmccaughey@northshore.org or 847.663.8510