A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT07668388
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • UBT251 — DRUG
    UBT251 will be administered subcutaneously once-weekly.
  • UBT251 Placebo — DRUG
    UBT251 placebo will be administered subcutaneously once-weekly.
  • Semaglutide — DRUG
    Semaglutide will be administered subcutaneously once-weekly.
  • Semaglutide Placebo — DRUG
    Semaglutide placebo will be administered subcutaneously once-weekly.

Study Details

The study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes. Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. Which treatment participants get is decided by chance. UBT251 is the treatment being tested and is not yet available for doctors to prescribe, while semaglutide is a medicine used to treat type 2 diabetes that doctors can already prescribe.

Key Dates

Start date
Jun 22, 2026
Status verified
Jun 2026
Primary completion
Oct 4, 2027
Completion
Nov 15, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UBT251
    Participants will receive once weekly UBT251 subcutaneously.
  • Placebo Comparator: UBT251 Placebo
    Participants will receive once weekly UBT251 placebo subcutaneously.
  • Active Comparator: Semaglutide
    Participants will receive once weekly semaglutide subcutaneously.
  • Placebo Comparator: Semaglutide Placebo
    Participants will receive once weekly semaglutide placebo subcutaneously.

Primary Outcome Measure

UBT251: Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to 12 weeks on a given maintenance dose (week 16, 28 and 40) ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
Flourish ResearchBirminghamAlabama35205-
Ark Clinical ResearchFountain ValleyCalifornia92708-
Ark Clinical ResearchLong BeachCalifornia90815-
Los Angeles Institute for Metabolic ResearchLos AngelesCalifornia90015-
Catalina Research Institute, LLCMontclairCalifornia91763-
Encore Medical Research LLCHollywoodFlorida33021-
South Broward Research LLCMiramarFlorida33027-
Encore Medical Research of WestonWestonFlorida33331-
Midwest Inst For Clin ResIndianapolisIndiana46260-
Cotton O'Neil Diabetes & EndocrinologyTopekaKansas66606-
MD Medical ResearchOxon HillMaryland20745-
PharmQuestGreensboroNorth Carolina27408-
KDCILM, LLC & Accellacare US, Inc.WilmingtonNorth Carolina28401-
Plains Clinical Research Center, LLC_FargoFargoNorth Dakota58104-
Preferred Primary Care Physicians, Inc.UniontownPennsylvania15401-
Monroe Biomedical Research, LLCNorth CharlestonSouth Carolina29406-
LifeDoc HealthMemphisTennessee38115-
IMA Clinical ResearchAustinTexas78745-
Private Practice - Dr. Laila A. HassanHoustonTexas77089-
Radiance Clinical ResearchLampasasTexas76550-
Quality Research IncSan AntonioTexas78209-
Tekton Research IncSan AntonioTexas78258-
Consano Clin Res-Shavano ParkShavano ParkTexas78231-
Chrysalis Clinical ResearchSt. GeorgeUtah84790-
The Vancouver ClinicVancouverWashington98664-

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