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NCT07616206 · ClinicalTrials.gov registry record · Phase 2

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems

A Phase 2 study, sponsored by vTv Therapeutics.

Not yet
Registry status
Phase 2
Development phase
40
Enrollment target

NCT07616206: Clinical Trial Phase 2 study, sponsored by vTv Therapeutics.

NCT07616206 is a Phase 2 study that has not yet begun recruiting, run by vTv Therapeutics. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07616206, a Phase 2 study, has not yet begun recruiting, sponsored by vTv Therapeutics.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manager their diabetes. Patients using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the treatment arm that they did not receive in the first treatment period.

Primary Outcome

Time in Range (TIR) based on study CGM in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo

Interventions

  • DRUG Placebo
  • DRUG Cadisegliatin 800 mg QD

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2026-07
Est. Completion 2027-05
Phase Phase 2
vTv Therapeutics

13 total trials

What is known before NCT07616206 opens enrollment

NCT07616206 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT07616206 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07616206 about?

NCT07616206 is a clinical study titled "Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems". TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manager their diabetes. Patients using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded c...

What is the current status of trial NCT07616206?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2026-07. Estimated completion is 2027-05.

What interventions are being tested in trial NCT07616206?

The interventions under investigation include: Placebo (DRUG), Cadisegliatin 800 mg QD (DRUG).

Who is sponsoring clinical trial NCT07616206?

This trial is sponsored by vTv Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07616206's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07616206, the US trial registry maintained by the National Library of Medicine. NCT07616206 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.