RG6652 / Roche - LARVOL DELTA

BP45932: A Study to Track How the Healthy Male Participants Handles the New Oral Drug RO7795081 for Weight Management and Diabetes (clinicaltrialsregister.eu) - P1 | N=10 | Active, not recruiting | Sponsor: F. Hoffmann-La Roche AG | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders

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: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

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

BP45932: A Study to Track How the Healthy Male Participants Handles the New Oral Drug RO7795081 for Weight Management and Diabetes (clinicaltrialsregister.eu) - P1 | N=10 | Not yet recruiting | Sponsor: F. Hoffmann-La Roche AG

New P1 trial • Diabetes • Metabolic Disorders

BP45932: A Study to Track How the Healthy Male Participants Handles the New Oral Drug RO7795081 for Weight Management and Diabetes (clinicaltrialsregister.eu) - P1 | N=10 | Recruiting | Sponsor: F. Hoffmann-La Roche AG | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders

BP45703: A Study to Compare Different Doses of RO7795081 with a Placebo or Semaglutide in People with Type 2 Diabetes (clinicaltrialsregister.eu) - P1/2 | N=74 | Recruiting | Sponsor: F. Hoffmann-La Roche AG

New P1/2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

BP46037: A study investigating the safety, absorption, and elimination of RO7795081, annew compound that may potentially be used in the treatment of type 2 diabetes and weight control (clinicaltrialsregister.eu) - P1 | N=0 | Active, not recruiting | Sponsor: F. Hoffmann-La Roche AG

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

In Structure licensing deal, Roche commits $100M to shore up GLP-1 position (FierceBiotech) - "The agreement grants Roche and its subsidiary Genentech a nonexclusive license to certain patents related to CT-996, the oral GLP-1 drug the Swiss pharma gained from its $2.7 billion buyout of Carmot Therapeutics. Besides the one-time $100 million payment, Roche will also pay Structure’s subsidiary, Gasherbrum Bio, royalties in the low-single-digit range on future net sales of CT-996-related products...The license could help the Swiss pharma avoid potential future patent infringement claims....Now, with the patent licensing deal, it appears Roche isn’t interested in a takeout of Structure."

Licensing / partnership • 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 | 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