NNC0480-0389 / Novo Nordisk - LARVOL DELTA

CO-ADMINISTERED SEMAGLUTIDE AND GLUCOSE-DEPENDENT INSULINOTROPIC PEPTIDE RECEPTOR AGONIST COMPARED WITH MONOTHERAPIES AND PLACEBO IN PEOPLE WITH TYPE 2 DIABETES: A RANDOMISED, DOSE-FINDING, PHASE 2 TRIAL (ATTD 2024) - P2 | "Background and Aims: This phase 2 trial (NCT05144984) was designed to determine the dose ratio, efficacy and safety of a proposed fixed-dose combination of the glucagon-like peptide-1 analogue, semaglutide, and the glucose-dependent insulinotropic peptide receptor agonist (GIPRA), NNC0480-0389. This was a randomised, double-blind, placebo-controlled, dose-finding trial including adults with type 2 diabetes (HbA1c 7–10%) treated with diet and exercise with/without metformin... Semaglutide co-administered with GIPRA was superior to placebo and GIPRA monotherapy, but did not improve glycaemic control more than semaglutide monotherapy, in this population. No new safety concerns were identified with co-administration or GIPRA monotherapy compared with semaglutide monotherapy.Funding: Funded by Novo Nordisk A/S."

Clinical • P2 data • Diabetes • Gastrointestinal Disorder • Metabolic Disorders • Type 2 Diabetes Mellitus

A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=500 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB • CRP

A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Chinese Men (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed | Trial completion date: Feb 2023 ➔ Oct 2022 | Trial primary completion date: Feb 2023 ➔ Oct 2022

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

A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=495 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting | Trial primary completion date: Oct 2022 ➔ Jan 2023

Combination therapy • Enrollment closed • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB • CRP

A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Diabetes • Long-acting Reversible Contraceptives • Metabolic Disorders • Type 2 Diabetes Mellitus

A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

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

A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Chinese Men (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Novo Nordisk A/S

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

A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes. (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: Novo Nordisk A/S

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

First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes (clinicaltrials.gov) - P1 | N=152 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

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

A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

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

A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: Novo Nordisk A/S; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Long-acting Reversible Contraceptives • Metabolic Disorders • Type 2 Diabetes Mellitus

A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: Novo Nordisk A/S

Clinical • New P1 trial • Diabetes • Long-acting Reversible Contraceptives • Metabolic Disorders • Type 2 Diabetes Mellitus

A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes (clinicaltrials.gov) - P2; N=495; Not yet recruiting; Sponsor: Novo Nordisk A/S

Clinical • Combination therapy • New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB • CRP

A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes (clinicaltrials.gov) - P2; N=495; Recruiting; Sponsor: Novo Nordisk A/S; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB • CRP

A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People (clinicaltrials.gov) - P1; N=16; Active, not recruiting; Sponsor: Novo Nordisk A/S; Recruiting ➔ Active, not recruiting

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

A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Novo Nordisk A/S; Not yet recruiting ➔ Recruiting

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

A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: Novo Nordisk A/S

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

A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Novo Nordisk A/S; Not yet recruiting ➔ Recruiting

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

A research study looking at how well a combination of the medicines semaglutide and NNC0480-0389 works in people with type 2 diabetes (clinicaltrialsregister.eu) - P2; N=495; Ongoing; Sponsor: Novo Nordisk A/S

Clinical • Combination therapy • New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB • CRP

A Research Study Looking Into Blood Levels of the Medicine NNC0480-0389 in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Novo Nordisk A/S

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

A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Novo Nordisk A/S; Recruiting ➔ Completed

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

A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Novo Nordisk A/S; Not yet recruiting ➔ Recruiting

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

A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Novo Nordisk A/S

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

First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes (clinicaltrials.gov) - P1; N=156; Recruiting; Sponsor: Novo Nordisk A/S; Active, not recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes (clinicaltrials.gov) - P1; N=156; Active, not recruiting; Sponsor: Novo Nordisk A/S; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus