RG6641 / Roche - LARVOL DELTA

A Study of CT-868 in Type 1 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=111 | Active, not recruiting | Sponsor: Carmot Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2024 ➔ Jul 2025 | Trial primary completion date: Oct 2024 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus

A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants with Type 1 Diabetes (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Carmot Therapeutics, Inc. | Recruiting ➔ Completed | N=24 ➔ 32

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

Carmot Therapeutics Announces Completion of Acquisition by Roche (Yahoo Finance) - "Carmot Therapeutics Inc...today announced that its acquisition by the Roche Group (Roche) has been completed....The acquisition gives Roche access to Carmot’s differentiated portfolio of incretins including: CT-388, the lead asset, is a Phase-2 ready, dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes. Injected subcutaneously once a week, it has potential as a standalone and combination therapy to improve weight loss and to be expanded to other indications. CT-996, a once-daily oral, small molecule GLP-1 receptor agonist currently in Phase-1 intended to treat obesity in patients with and without type 2 diabetes. CT-868, a Phase-2, once-daily subcutaneous injectable, dual GLP-1/GIP receptor agonist intended for the treatment of type 1 diabetes patients with overweight or obesity."

M&A • Diabetes • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Roche enters into a definitive merger agreement to acquire Carmot Therapeutics, including three clinical stage assets with best-in-class potential in obesity and diabetes (GlobeNewswire) - "Roche...announced today the entry into a definitive merger agreement to acquire Carmot Therapeutics, Inc...The acquisition gives Roche access to a differentiated portfolio of incretins including: CT-388, the lead asset is a Phase-2 ready, dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes....CT-996, a once-daily oral, small molecule GLP-1 receptor agonist currently in Phase-1 intended to treat obesity in patients with and without type 2 diabetes. CT-868, a Phase-2, once-daily subcutaneous injectable, dual GLP-1/GIP receptor agonist intended for the treatment of type 1 diabetes patients with overweight or obesity....Under the terms of the agreement, Roche will pay Carmot’s equity holders a purchase price of USD 2.7 billion in cash at the closing of the transaction."

M&A • Diabetes • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity • Type 2 Diabetes Mellitus

Carmot Therapeutics Commenced Phase 2 Clinical Trial of Novel Dual GLP-1/GIP Receptor Agonist CT-868 for the Treatment of Type 1 Diabetes (GlobeNewswire) - "Carmot Therapeutics Inc...announced that it has commenced a Phase 2 clinical trial of its once-daily dual GLP-1/GIP receptor agonist, CT-868, in adult participants with overweight or obesity with T1D....Carmot anticipates enrolling approximately 95 participants at clinical trial centers across the United States. All participants will continue to receive insulin therapy using either an insulin pump or multiple daily insulin injections, and all participants will wear a CGM device throughout the clinical trial."

Trial status • Diabetes • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus

A Study of CT-868 in Type 1 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Carmot Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus

Carmot Therapeutics Highlights Clinical Data from its Pipeline of Treatments for Obesity and Diabetes at ObesityWeek (GlobeNewswire) - "Carmot Therapeutics Inc...today announced positive results...at ObesityWeek October 14-17, 2023....In this rodent study....CT-859, a fully cAMP-biased dual GLP-1/GIP RA that exhibits no β-arrestin coupling at either receptor, was administered to GLP-1R knockout (KO) mice and wildtype (WT) mice by intracerebroventricular injection. The results from this study are as follows: CT-859 had no effect in the GLP-1R KO mice, but decreased food intake and body weight in WT mice in a dose-dependent manner even after 24 hours post-dose. CT-859 produced greater reduction in body weight and food intake when compared to liraglutide at the same dose. Biased signaling in the central nervous system is important to induce a sustained effect on food intake suppression and weight loss; these effects are centrally mediated."

Preclinical • Metabolic Disorders • Obesity

Carmot Therapeutics Highlights Clinical Data from its Pipeline of Treatments for Obesity and Diabetes at ObesityWeek (GlobeNewswire) - P2 | N=103 | NCT04838405 | Sponsor: Carmot Therapeutics, Inc. | "HbA1c improved significantly from baseline in CT-868 arms compared with placebo at Week 26 with a mean treatment difference in HbA1c for CT-868 4.0 mg vs. placebo of -2.31% (95% CI -3.03 to -1.58, p<0.001). Approximately 70% of participants treated with CT-868 achieved HbA1c in the non-diabetes range (< 6.5%) compared to ~18% of participants who received placebo (p<0.01). Significant improvements in cardiovascular risk factors such as lipid parameters and blood pressure were observed across the CT-868 treated groups relative to those treated with placebo. CT-868 was well-tolerated with no treatment-related discontinuation, with the most common adverse effects being GI-related and mostly mild in severity. No clinically significant hypoglycemia was reported. These data support continued investigation of CT-868 at higher doses in future studies."

P2 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of CT-868 in Type 1 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=96 | Not yet recruiting | Sponsor: Carmot Therapeutics, Inc.

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

Carmot Therapeutics Announces Two Oral Presentations Featuring Clinical Data from its Pipeline of Treatments for Obesity and Diabetes at the 59th European Association for the Study of Diabetes (EASD) Annual Meeting (GlobeNewswire) - "Phase 1 data for CT-388, a once-weekly injectable, dual GLP-1/GIP receptor agonist in development for the treatment of obesity and type 2 diabetes; Phase 1b data for CT-868, a once-daily injectable, dual GLP-1/GIP receptor agonist in development for the treatment of type 1 diabetes with overweight or obesity...Carmot Therapeutics Inc...announced two oral presentations to take place at the European Association for the Study of Diabetes Annual Meeting from October 2-6, 2023 in Hamburg, Germany."

P1 data • Diabetes • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity • Type 2 Diabetes Mellitus

A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants With Type 1 Diabetes (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Carmot Therapeutics, Inc.

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=96 | Active, not recruiting | Sponsor: Carmot Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose. (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Carmot Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose. (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Carmot Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Carmot Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2; N=96; Not yet recruiting; Sponsor: Carmot Therapeutics, Inc.

Clinical • New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose. (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Carmot Therapeutics, Inc.

Clinical • New P1 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus