RG6652 / Roche - LARVOL DELTA

CT-996-201: Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=94 | Completed | Sponsor: Carmot Australia First Pty Ltd | Active, not recruiting ➔ Completed

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

CT-996-201: Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=94 | Active, not recruiting | Sponsor: Carmot Australia First Pty Ltd | Recruiting ➔ Active, not recruiting

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

A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity (clinicaltrials.gov) - P2 | N=340 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2025 ➔ May 2026 | Trial primary completion date: Dec 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

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

A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Hoffmann-La Roche

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity (clinicaltrials.gov) - P2 | N=340 | Recruiting | Sponsor: Hoffmann-La Roche

New P2 trial • Genetic Disorders • Obesity

A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081 (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion

CT-996-201: Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Carmot Australia First Pty Ltd | Trial completion date: Nov 2024 ➔ Oct 2025 | Trial primary completion date: Nov 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P1 trial • Genetic Disorders • Obesity

A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081 (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081 (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Hoffmann-La Roche

New P1 trial

Safety, pharmacokinetics, and pharmacodynamics of CT-996, an oral small molecule, signal biased GLP-1 receptor agonist over 4 weeks in adults with obesity (EASD 2024) - "There is no abstract associated with this presentation."

Clinical • PK/PD data • Metabolic Disorders • Obesity

S46. Hot press-release: CT-996, an oral small molecule, signal-biased GLP-1RA in adults with obesity (EASD 2024) - No abstract available

Clinical • Metabolic Disorders • Obesity

[Ad hoc announcement pursuant to Art. 53 LR] Roche announces positive Phase I results of its oral GLP-1 receptor agonist CT-996 for the treatment of people with obesity (Roche Press Release) - P1 | N=118 | NCT05814107 | Sponsor: Carmot Australia First Pty Ltd | "Roche...announced today positive topline results from two arms of an ongoing multi-part Phase I clinical trial for CT-996...The data showed that treatment with CT-996 in participants with obesity and without type 2 diabetes resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within four weeks (p <0.001). The full study data will be presented at an upcoming medical meeting...CT-996 was well tolerated, with mostly mild or moderate gastrointestinal-related adverse events, consistent with the safety profile of the incretin drug class. There were no treatment discontinuations related to the study drug. The study results also showed that blood levels of CT-996 were largely unaffected either during fasting or after a standardised high-fat meal."

P1 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy of CT-996, an Oral Small Molecule GLP-1 Receptor Agonist, in Human GLP-1 Receptor Knockin Mice and Obese Cynomolgus Monkeys (ADA 2024) - "Since FDA approval of exenatide in 2005, injectable GLP-1 receptor agonists (RAs) have established their clinical utility in the management of type 2 diabetes and obesity. These observations corroborate the continued development of CT-996 as a next-generation GLP-1RA. CT-996 is currently being evaluated in a Phase 1 clinical trial."

Preclinical • Diabetes • Metabolic Disorders • Obesity • Type 2 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 Announces that Preliminary Phase 1 Results Support Once-daily Oral Dosing for its Obesity and Type 2 Diabetes Candidate CT-996 (GlobeNewswire) - P1 | N=118 | NCT05814107 | Sponsor: Carmot Australia First Pty Ltd | "Carmot Therapeutics, Inc...today announced preliminary data from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial for CT-996, an oral small molecule GLP-1 receptor agonist (RA) currently being evaluated in a first-in-human clinical trial in participants with obesity or overweight. Preliminary Phase 1 pharmacokinetic (PK) results support once-daily (QD) oral dosing of CT-996. Tolerability results have been consistent with the GLP-1 RA class with the majority of the adverse events being gastrointestinal-related and mostly mild in severity."

P1 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=118 | Recruiting | Sponsor: Carmot Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

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

Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=118 | Not yet recruiting | Sponsor: Carmot Therapeutics, Inc.

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