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Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Nov 2026 → Feb 2027
See other at-risk trials from Gilead Sciences

Record History

  1. Primary and study completion pushed from Nov 2026 to Feb 2027 Eligibility criteria expanded, about 25 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 25 words
  2. Primary and study completion pushed from Jul 2026 to Nov 2026v8
  3. Site details revised at 1 of 3 sitesv7
  4. Study sites: 2 to 3v6
  5. Eligibility criteria expanded, about 10 wordsv5 See this version in full on ClinicalTrials.gov ↗
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Study sites: 1 to 2v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Aug 2024 to Aug 28, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 2024 to Aug 28, 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Gilead Sciences
113 trials monitored
See 11 trials at risk
Obesity
3,560 trials monitored
See 142 trials at risk
The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM). The primary objectives of this study are: * To characterize the pharmacokinetics (PK) of GS-4571 following single and multiple ascending oral doses of GS-4571. * To evaluate the effect of concomitant food intake and (if conducted) a representative acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571. * To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.
Trial Details
NCT Number NCT06562907
Lead Sponsor Gilead Sciences
Conditions Weight Management
Enrollment 134 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov