A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

Conditions

• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cagrilintide — DRUG
  Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose 1 and dose 2 of cagrilintide is reached.
• Semaglutide — DRUG
  Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose 1 and dose 2 of semaglutide is reached.
• Placebo cagrilintide — DRUG
  Participants will receive placebo matched to cagrilintide subcutaneously.
• Placebo semaglutide — DRUG
  Participants will receive placebo matched to semaglutide subcutaneously.

Study Details

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

Key Dates

Start date

Sep 27, 2023

Status verified

Jan 2026

Primary completion

Nov 19, 2025

Completion

Jan 6, 2026

Study Design

Enrollment

2,734 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CagriSema Dose 1
  Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.
• Experimental: CagriSema Dose 2
  Participants will receive once-weekly s.c injections of cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.
• Active Comparator: Semaglutide Dose 1
  Participants will receive once-weekly s.c injection of semaglutide dose 1 for 68 weeks.
• Active Comparator: Semaglutide Dose 2
  Participants will receive once-weekly s.c injection of semaglutide dose 2 for 68 weeks.
• Active Comparator: Cagrilintide Dose 1
  Participants will receive once-weekly s.c injection of cagrilintide dose 1 for 68 weeks.
• Placebo Comparator: Placebo Dose 1
  Participants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.
• Placebo Comparator: Placebo Dose 2
  Participants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.

Primary Outcome Measure

CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]

Locations (101)

Related coverage on Hipa.ai

• CagriSema Phase 3 Trial for Type 2 Diabetes Reaches Primary Completion
  CagriSema (Cagrilintide B and Semaglutide I) · Nov 19, 2025 · ClinicalTrials.gov

Find similar trials in Birmingham, AL

Related Studies

• Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
  Recruiting · Petter Bjornstad · Aurora, Colorado
• Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
  PHASE3 · Recruiting · Prokidney · Huntsville, Alabama
• Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
  Recruiting · Endogenex, Inc. · Birmingham, Alabama
• An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
  Recruiting · Bayer · Multiple Locations, New Jersey