A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide \[2 milligrams (mg), 8 mg, or 16 mg\] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.

Key facts

Study ID

NCT05486065

Run by

Novo Nordisk A/S

People needed

245

Starts

2022-08-08

Expected to finish

2023-12-13

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female.
• Aged 18-64 years (both inclusive) at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.
• Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) [53 - 91 millimoles per mole (mmol/mol)] (both inclusive).
• Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m\^2).
• Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.

You may not qualify if…

• 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 prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of 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.
• Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 30 milliliters per minute (mL/min)/1.73 meter square (m\^2) at screening.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Velocity Clinical Res-Banning — Banning, California, United States
• Velocity Clin Res-Chula Vista — Chula Vista, California, United States
• Southern California Res Ctr — Coronado, California, United States
• Cedars-Sinai Medical Group — Encino, California, United States
• Velocity Clin Res Gardena — Gardena, California, United States
• Nat Res Inst Huntington Park — Huntington Park, California, United States
• Scripps Whittier Diabetes Inst — La Jolla, California, United States
• First Valley Med Grp Lancaster — Lancaster, California, United States
• Velocity Clin Res Los Angeles — Los Angeles, California, United States
• Diabetes Assoc. Med Group — Orange, California, United States
• Western University of Health Sciences — Pomona, California, United States
• San Diego Family Care_San Diego — San Diego, California, United States
• Mills-Peninsula Hlth Services — San Mateo, California, United States
• Encompass Clinical Research_Spring Valley — Spring Valley, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Optumcare Clinical Trials,LLC-Golden — Colorado Springs, Colorado, United States
• Innovative Research of W FL — Clearwater, Florida, United States
• Tampa Bay Medical Research — Clearwater, Florida, United States
• Alliance for Multispec Res — Coral Gables, Florida, United States
• University Clin Res-Deland — DeLand, Florida, United States
• Northeast Research Institute — Fleming Island, Florida, United States
• Indago Research & Health Center Inc. — Hialeah, Florida, United States
• Northeast Res Inst. Inc. — Jacksonville, Florida, United States
• Univ of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.