Table 1.
An overview of ongoing, recruiting, and upcoming trials of anti-obesity medications as adjunct therapies in T1D.
| Adjunct medication | ClinicalTrials.gov identifier | Phase(s) | Age inclusion (years) | Estimated sample size | BMI inclusion (kg/m2) | Other intervention(s) | Placebo-controlled | Primary outcome | |
|---|---|---|---|---|---|---|---|---|---|
| Measure(s) | Timeframe | ||||||||
| GLP1-RA | |||||||||
| GLP1 | NCT04355832b | 1 | 18−50 | 40 | <40 | / | ✓ | Catecholamines levels | 3 years |
| Liraglutide | NCT02516657c | 3 | 15−21 | 5 | NR | / | Mean weekly blood glucose | 2 weeks | |
| Liraglutide | NCT03011021b | 1 and 2 | ≥18 | 40 | NR | Umbilical cord blood-T regulatory cells infusion [biological] | Adverse events and signs of toxicity | 2 years | |
| Liraglutide | NCT05794581b | 1 | 18−65 | 24 | 25−35 | CT-868 [dual GLP1 and GIP receptor modulator] | ✓ | Area under the curve in glucose metabolism | Up to 4 days |
| Liraglutide | NCT03182426c | 1 and 2 | 18−45 | 60 | <35 | Plerixafor, Alemtuzumab Anakinra Etanercept | C-peptide area under curve and serious adverse event rate | 3, 6, 9, 12, 18 and 24 months | |
| Semaglutide | NCT05537233b | 2 | 18−60 | 80 | ≥30 | ✓ | Continuous glucose monitoring-measured time in range >70% with time below range of <4% and reduction in body weight by 5% | 26 weeks | |
| Semaglutide | NCT05819138b | 3 | 18−40 | 60 | 20−35 | ✓ | Central and peripheral arterial stiffness | 4 weeks | |
| Semaglutide | NCT05822609a | 2 | ≥18 | 60 | NR | ✓ | Kidney cortical relaxation rate | 26 weeks | |
| Semaglutide | NCT05205928b | 2 and 3 | ≥18 | 28 | ≥22 | Closed-loop insulin system | ✓ | Percentage of time of plasma glucose levels spent in target range (3.9 to 10.0 mmol/L) | 4 weeks |
| Dulaglutide | NCT05478707a | 2 | 18−40 | 64 | 19−27 | Exercise training | ✓ | Microvascular blood volume | 14 weeks |
| SGLT2 inhibitor | |||||||||
| Sotagliflozin | NCT05696366a | 1 and 2 | 18−70 | 22 | 18.5−35 | Volagidemab | ✓ | HbA1c changes | 12 weeks |
| Dapagliflozin | NCT05541484b | 4 | 18−75 | 20 | NR | Biosense breath ketone analyser | Blood and breath ketone levels | 4 weeks | |
| Dapagliflozin | NCT04333823b | 3 | 12−18 | 100 | Within 99.9th percentile | / | ✓ | Glomerular filtration rate | 16 weeks |
| Dapagliflozin | NCT04049110b | 3 | 18−65 | 24 | 20−29 | / | Mean amplitude of Glucose Excursions upon exercise | From completion of physical exercise at day 7 of each intervention period to 72 h after | |
| Dapagliflozin | NCT03878459b | 4 | ≥18 | 120 | NR | Pioglitazone, | ✓ | HbA1c change | 28 weeks |
| Dapagliflozin | NCT03704818c | 1 | 18−70 | 22 | 18.5−35.0 | / | ✓ | Counterregulatory response to hypoglycaemia | 12 weeks |
| GLP1-RA + SGLT2 inhibitor | |||||||||
| Liraglutide, semaglutide, dapagliflozin | NCT05390307a | N/A | 21−65 | 60 | ≥25 | Intensive nutrition, bariatric surgery, and usual care | Weight change | 26 weeks | |
| Semaglutide, dapagliflozin | NCT03899402b | 2 and 3 | 18−75 | 114 | ≥25 | Insulin | ✓ | HbA1c change | 6 months |
A search was conducted on ClinicalTrials.gov on June 21, 2023 to identify registered trials.
GIP glucose-dependent insulinotropic polypeptide, GLP1-RA glucagon-like peptide-1 receptor agonists, SGLT2 sodium-glucose cotransporter-2.
NR not reported, N/A non-applicable.
aNot yet recruiting.
bRecruiting.
cActive, not recruiting.