exenatide implant (NPM-119) / Vivani Medical - LARVOL DELTA

LIBERATE-1: Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Vivani Medical, Inc | Active, not recruiting ➔ Completed

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

LIBERATE-1: Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Vivani Medical, Inc | Not yet recruiting ➔ Active, not recruiting

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

LIBERATE-1: Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Vivani Medical, Inc | N=16 ➔ 24 | Trial completion date: Jan 2025 ➔ Aug 2025 | Trial primary completion date: Jan 2025 ➔ Aug 2025

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

Vivani Medical Announces FDA Clears Investigational New Drug Application and Lifts Clinical Hold for NPM-119, a Miniature Long-Term Subdermal GLP-1 Drug Implant (Yahoo Finance) - "Vivani Medical, Inc...today announced the U.S. Food and Drug Administration has cleared the Investigational New Drug Application ('IND') and lifted the clinical hold on NPM-119 to allow initiation of LIBERATE-1, a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of NPM-119 (exenatide), the Company’s miniature, six-month GLP-1 implant in development for the treatment of type 2 diabetes."

FDA event • IND • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Vivani Medical Provides Business Update and Reports First Quarter 2024 Financial Results (Businesswire) - "Vivani anticipates filing the NPM-115 IND application in the second half of 2024 and initiating a first-in-human trial after receiving regulatory clearance to proceed. Vivani remains on track to provide the FDA with the requested CMC information associated with the current Clinical Hold on NPM-119 during the first half of 2024. Vivani plans to participate in multiple external events, including the TIDES USA conference on Oligonucleotide and Peptide Therapeutics on May 17, 2024 in Boston, MA, where Dr. Mendelsohn will present new NPM-115 data, as well as the Annual BIO International Conference in San Diego, CA on June 3-5, 2024, where Dr. Mendelsohn and Vivani’s Chief Business Officer Don Dwyer will meet with potential partners, investors and other industry representatives."

Clinical • FDA event • IND • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

LIBERATE-1: Assessment of Safety, Tolerability and Drug Levels of NPM-119 in Participants With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Vivani Medical, Inc | Phase classification: P2a ➔ P1 | N=48 ➔ 16 | Trial completion date: Jun 2024 ➔ Jan 2025 | Initiation date: Sep 2023 ➔ Mar 2024

Enrollment change • Phase classification • Trial completion date • Trial initiation date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Vivani Medical to Present at the Boulder Peptide Symposium (Businesswire) - "Vivani Medical, Inc...announced today that it will present at the upcoming Annual Boulder Peptide Symposium at 11:20 am PST at the Napa Valley Marriott Hotel and Spa in Napa, California on September 19, 2023. Dr. Adam Mendelsohn, CEO, will provide updates on the company, its proprietary NanoPortal™ implant technology and the company’s lead program, NPM-119, a miniaturized, 6-month, GLP-1 implant currently under development for the treatment of type 2 diabetes and obesity."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Vivani Medical Reports Second Quarter Financial Results and Provides Business Update (Businesswire) - "The Company expects to commence enrollment of patients in LIBERATE-1, its Phase 2 trial of NPM-119 in patients with type 2 diabetes, in the second half of 2023 subject to regulatory clearance. Assuming LIBERATE-1 commences as planned, the Company would anticipate the availability of interim LIBERATE-1 data in the first half of 2024 and full top-line results in the second half of 2024."

Enrollment status • New P2 trial • P2 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

LIBERATE-1: Assessment of Safety, Tolerability and Drug Levels of NPM-119 in Participants With Type 2 Diabetes (clinicaltrials.gov) - P2a | N=48 | Not yet recruiting | Sponsor: Vivani Medical, Inc | Trial completion date: Dec 2023 ➔ Jun 2024 | Initiation date: Mar 2023 ➔ Sep 2023 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Trial completion date • Trial initiation date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

LIBERATE-1: Assessment of Safety, Tolerability and Drug Levels of NPM-119 in Participants With Type 2 Diabetes (clinicaltrials.gov) - P2a | N=60 | Not yet recruiting | Sponsor: Vivani Medical, Inc

New P2a trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus