pramlintide/insulin A21G (ADO09) / Adocia, Sanofi - LARVOL DELTA

ADOCIA Reports First Quarter 2025 Financial Results and Provides a Business Update (Businesswire) - "Business priority for 2025 remains establishing partnerships for M1Pram with Sanofi and for BioChaperone CagriSema."

Commercial • Obesity • Type 1 Diabetes Mellitus

M1Pram – Ongoing exclusive discussions with Sanofi (Businesswire) - "M1Pram is a fixed combination of insulin and amylin analogs aimed at addressing the unmet medical need of obesity in insulin-dependent individuals...A Phase 2b clinical program in the United States, involving 140 patients with Type 1 Diabetes and a BMI5>30kg/m², is in preparation...Adocia has completed the manufacturing of clinical batches. The launch of the clinical trial is conditional on entering an agreement for its financing."

Commercial • New P2b trial • Type 1 Diabetes Mellitus

ADO09, a co-formulation of pramlintide and insulin A21G, lowers body weight versus insulin lispro in type 1 diabetes. (PubMed, Diabetes Obes Metab) - "These results extend previous observations on the efficacy and safety of this insulin/pramlintide co-formulation. They show a beneficial effect on weight, using less mealtime insulin and without increased hypoglycaemia."

Journal • Diabetes • Gastrointestinal Disorder • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

A co-formulation of pramlintide and insulin A21G (ADO09) improves post-prandial glucose and short-term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes. (PubMed, Diabetes Obes Metab) - "In comparison with aspart, ADO09 was well tolerated and effective in T1D across a wide range of dosage, significantly improving the average blood glucose level and body weight during 24 days of ambulatory treatment. Meal test profiles confirmed improvement of glycaemic patterns and other responses with ADO09."

Journal • Diabetes • Gastrointestinal Disorder • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Ado09, a co-formulation of pramlintide and insulin A21G, improves body weight and treatment satisfaction compared to insulin lispro in people with type 1 diabetes (PwT1D) (EASD 2022) - P2 | "Materials and During a run-in period of 2-4 weeks, basal insulin was switched to insulin degludec or glargine and continuous glucose monitoring (CGM) initiated... In this 4 months treatment study in PwT1D, ADO09 showed similar overall effects on glycaemic control and hypoglycaemia to LIS, but significantly lowered body weight and improved treatment satisfaction."

Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM) (clinicaltrials.gov) - P2 | N=80 | Completed | Sponsor: Adocia | Recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

[VIRTUAL] Ado09, a co-formulation of pramlintide and insulin A21G improves post-prandial glucose and body weight versus insulin aspart in type 1 diabetes (EASD 2021) - P1/2 | "Part A was conducted in participants using less than 40 U prandial insulin per day, part B in subjects using 40 to 75 U prandial insulin per day.Materials and During a 28 days run-in period, basal insulin was switched to insulin degludec and titrated... ADO09 was well tolerated and significantly improved post-prandial blood glucose control, hyperglucagonemia, CGM-metrics and body weight versus insulin aspart over 24 days across a wide range of prandial insulin doses."

Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM) (clinicaltrials.gov) - P2; N=80; Recruiting; Sponsor: Adocia

Clinical • New P2 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus