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A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary and study completion pushed from Oct 2026 to Feb 2027
    • Enrollment target: 138 to 150
    • Eligibility criteria expanded, about 27 words
    v7
  2. Enrollment target: 126 to 138v6 Show 4 more changesShow less
    • Primary and study completion dates: Jul 2026 to Oct 2026
    • Start date: May 7, 2025 to May 9, 2025
    • Eligibility criteria expanded, about 4 words
    • Study title expanded, about 1 word
  3. Study sites: 1 to 8v5
  4. Re-verified, no change to tracked fieldsv4
  5. Primary and study completion dates: Dec 10, 2026 to Jul 2026
    • Start date changed from estimate of May 29, 2025 to May 7, 2025
    • Site contact updated
    v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 90 to 126
    • Study sites: 0 to 1
    • Primary and study completion dates: Aug 31, 2027 to Dec 10, 2026
    • Start date: Jun 9, 2025 to May 29, 2025
    • Interventions: ARO-ALK7 (Drug), Placebo (Drug), Tirzepetide (Drug) to ARO-ALK7 (Drug), Placebo (Drug)
    • Study arms: 5 to 4
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Arrowhead Pharmaceuticals
35 trials monitored
See 3 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at risk
This is a Phase 1/2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-ALK7 in adult participants with obesity without Type 2 Diabetes Mellitus (T2DM) (Part 1), and the safety, tolerability, and PD of multiple doses of ARO-ALK7 in adult participants with obesity with and without T2DM, either as monotherapy or in combination with tirzepatide (Part 2).
Trial Details
NCT Number NCT06937203
Lead Sponsor Arrowhead Pharmaceuticals
Conditions
(from sponsor)		 Obesity, Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Type 2, Obesity
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov