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NCT07479862

A Study of SA030 Injection in Overweight/Obese Participants With or Without Type 2 Diabetes Mellitus (T2DM)

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 8 months later.

See at-risk trials from Suzhou Siran Biotechnology Co.,Ltd.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial arms changed: 2 → 3
    • Secondary endpoints: 17 to 18
    • Site contacts updated at 2 of 2 sites
    • Study title expanded, about 6 words
  2. Primary and study completion dates pushed to Apr 24, 2028 Show 5 more changesShow less
    • Recruitment opened
    • Eligibility criteria expanded, about 24 words
    • Interventions modified
    • Study sites: 1 to 2
    • Secondary endpoints: details revised at 3 of 17 entries
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Approximatly 12 months
Number of participants with clinical significant laboratory abnormalities
Timeframe: Approximatly 12 months

Secondary (18)

Peak plasma concentration (Cmax)
Time to peak plasma concentration (Tmax)
Plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)
Plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)
Elimination half-life (t1/2)
Show 13 moreShow less
Terminal elimination rate constant (λz)
Apparent volume of distribution (Vd/F)
Apparent clearance (CL/F)
Number and percentage of participants developing immunogenicity (anti-SA030 antibodies)
Changes in weight
Changes in BMI
Changes in waist circumference
Changes in hip circumference,
Changes in waist-to-hip ratio
Changes in body fat content
Change in hepatic fat content
Changes in ALK7 expression
Change in QTcF relative to baseline and relative to placebo compared to baseline

Arms and interventions

Single dose escalation of SA030Experimental

single dose, 5 dose levels 1,2 3, 4 \& 5

Multiple dose escalation of SA030 in obese participantsExperimental

Multiple dose, 3 dose levels.

Multiple dose escalation of SA030 in obese with T2DM participantsExperimental

multiple dose; 2 dose levels

Drugs: SA030 Injection, Matching Placebo

Sites

2 sites in 1 country