REIMAGINE-1 — structured trial abstract

§1Structured abstract

§1.1Objective

To evaluate Amycretin in obesity and overweight in adults, against the comparator specified in §2, with the primary endpoint stated below.

§1.2Design

Design

Phase 1 single- and multiple-ascending-dose study

Masking

Double-blind within dose cohort, sponsor-open

Phase

Phase 1

Randomised participants

125

Duration of the primary analysis period

Up to 36 weeks

Sponsor class

Manufacturer-sponsored

Registry identifier

not reproduced — see the note in §1.5

§1.3Primary endpoint

Safety, tolerability and pharmacokinetics of ascending subcutaneous and oral doses, with percentage change in body weight as an exploratory endpoint

§1.4Principal result

Exploratory weight reduction of approximately 13 % at 12 weeks with the subcutaneous presentation. The Institute treats an exploratory endpoint in a phase 1 study as hypothesis-generating and grades every amycretin efficacy claim very low certainty on that ground.

§1.5Provenance of this abstract

Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.