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UBT38006

Phase 1

Type 2 Diabetes Mellitus (T2DM) | Small molecule | Metabolic |United Therapeutics Corporation|Last Updated: Jul 20, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

UBT38006 · 1 trial · 1 indication

Phase 1 1
NCT07630233A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult MalesType 2 Diabetes Mellitus (T2DM)
NOT YET_RECRUITING53 Analytics
PHASE1NOT YET_RECRUITING
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males
Type 2 Diabetes Mellitus (T2DM)Unlock trial analytics

Study Endpoints

Primary Endpoints

incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,..
Baseline to Day43

Secondary Endpoints

GIRmax
Baseline to Day43
Tmax,GIR
Baseline to Day43
AUCGIR
Baseline to Day43
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
UBT38006EXPERIMENTALs.c, single dose
PlaceboPLACEBO_COMPARATORs.c, single dose
Insulin Degludec Active ControlACTIVE_COMPARATOR0.4U/kg Insulin Degludec Injection,single subcutaneous injection
Insulin Icodec Active ControlACTIVE_COMPARATOR1.25U/kg Insulin icodec Injection,single subcutaneous injection

Interventions

NameTypeDescription
UBT38006DRUGAscending single doses - 4 dose levels
PlaceboDRUGAscending single doses - 4 dose levels
Insulin Degludec InjectionDRUGsingle subcutaneous injection
Insulin Icodec InjectionDRUGsingle subcutaneous injection
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Aged 18-45 years (inclusive) at the time of informed consent form (ICF) signing; * Sex: Male; * Body weight ≥50.0 kg and body mass index (BMI) between 19.0-24.0 kg/m² (BMI = weight \[kg\] / height² \[m²\]), inclusive, at Screening; * Fasting plasma glucose (FPG) between 3.9-6....

Countries:China
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Recent Changes (Last 90 Days)

MEDIUMJul 26, 2026NCT07630233Enrollment: 43 → 53
MEDIUMJul 26, 2026NCT07630233Enrollment: 43 → 53
MEDIUMJul 26, 2026NCT07630233Enrollment: 43 → 53

Frequently asked questions about UBT38006

What is UBT38006 used for?

UBT38006 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus (T2DM). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes UBT38006?

UBT38006 is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR.

What phase is UBT38006 in?

UBT38006 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use. The ongoing Phase 1 trial is designed to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.

What clinical trials is UBT38006 in?

UBT38006 is being studied in a Phase 1 clinical trial registered as NCT07630233. This randomized, double-blind, placebo-controlled study is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of UBT38006 in healthy adult males.

Is UBT38006 being studied in healthy volunteers?

Yes, the ongoing Phase 1 trial of UBT38006 (NCT07630233) is enrolling healthy adult males aged 18 years and older. The study is placebo-controlled and is being conducted in China, with a planned enrollment of 53 participants.