RG6652 / Roche - LARVOL DELTA

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 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Safety and pharmacodynamics of CT-996, an oral small molecule, cAMP signal-biased GLP-1 receptor agonist, over 4 weeks in adults with overweight/obesity and type 2 diabetes (EASD 2026) - P1 | "The overall study population was 53% female with mean [SD] age 50.4 [9.9] years, HbA1c 8.2% [0.9], BMI 34.8 [5.8] kg/m², body weight 93.5 [16.4] kg, and 83% were on metformin. CT-996 was generally well tolerated over 4 weeks of treatment, with an AE profile consistent with rapid titration of the incretin class at this stage of development. There were no serious AEs or liver safety signals. Dose-dependent improvements in HbA1c, postprandial glucose control and body weight over 4 weeks support the continued clinical development of QD oral CT-996 in T2D."

Clinical • First-in-human • PK/PD data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Renal Disease

A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study Investigating the Safety of RO7795081 and How the Body Processes RO7795081 in People With Normal or Decreased Kidney Functions (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P1 trial • Renal Disease

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=352 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P1 trial • 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 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial initiation date • Diabetes • Metabolic Disorders • 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

Trial initiation 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 | 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