Clinical trial NCT04982575: Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
Official title: Efficacy and Safety of Co-administration of Cagrilintide s.c. 2.4 mg and Semaglutide s.c. 2.4 mg Once Weekly in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone.

Before a new medicine can be prescribed to people it needs to be tested to see if it is safe and effective.

Participants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine. Which treatment participants get is decided by chance.

A dummy medicine (placebo) looks like the study medicine but does not contain any active medicine. The dummy medicine is in the study to see if the study medicine works as expected.

Participants will get 2 injections per week on the same day. Participants will take the study medicine with a pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show how.

The study will last for about 39 weeks. Participants will have 12 visits at the clinic and 5 phone calls with the study doctor.

At 6 of the clinic visits participants must not eat and drink for 8 hours before the visit (water is allowed).

Women who can become pregnant cannot take part in this study. Only women that are surgically sterilised or post-menopausal are allowed to participate in this study Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period


Eligibility criteria: Inclusion Criteria:

* Female of non-childbearing potential or male
* Age above or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) greater than or equal to 27.0 kg/m\^2
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
* Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening
* Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at maximum tolerated or effective dose as judged by the investigator: metformin with or without Sodium-glucose co-transporter-2 (SGLT2) inhibitor

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73m\^2 by central laboratory at screening
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
timeFrame: Week 0, Week 32
Secondary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
timeFrame: Week 0, Week 32
measure: Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
timeFrame: Week 0, Week 32
measure: Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
timeFrame: Week 0, Week 32
measure: Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
timeFrame: Week 0, Week 32
measure: CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
timeFrame: Week 0, Week 32
measure: Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
timeFrame: At week 32
measure: Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
timeFrame: At week 32
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to week 37
measure: Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
timeFrame: From baseline (week 0) to week 37
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Uni of Alabama at Birmingham
state: Alabama
city: Los Alamitos
country: United States
facility: Pacific Clinical Studies
state: California
city: Los Angeles
country: United States
facility: Velocity Clin Res Wstlke
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research_Spring Valley
state: California
city: Golden
country: United States
facility: New West Physicians,Inc.
state: Colorado
city: Orlando
country: United States
facility: Florida Inst For Clin Res
state: Florida
city: Plantation
country: United States
facility: Clinical Trial Research Associates,Inc
state: Florida
city: Honolulu
country: United States
facility: East West Med Res Inst
state: Hawaii
city: Gillespie
country: United States
facility: Macoupin Research Group
state: Illinois
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC_Fargo
state: North Dakota
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Longview
country: United States
facility: DCOL Ctr for Clin Res
state: Texas
city: Olympia
country: United States
facility: Capital Clin Res Ctr,LLC
state: Washington
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 1452)
role: STUDY_DIRECTOR
References:
citation: Frias JP, Deenadayalan S, Erichsen L, Knop FK, Lingvay I, Macura S, Mathieu C, Pedersen SD, Davies M. Efficacy and safety of co-administered once-weekly cagrilintide 2.4 mg with once-weekly semaglutide 2.4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2023 Aug 26;402(10403):720-730. doi: 10.1016/S0140-6736(23)01163-7. Epub 2023 Jun 23.