Issue No. 03 · independently reviewed source log

Phase 3 is not approval: source log.

The compact ledger behind Issue 03. Every number, regulatory-status sentence, product-identity boundary, and link passed independent review on July 18, 2026.

9claims in the reviewed ledger

6primary or official sources

4milestones kept separate

0products ranked

Claim ledger

C-01

REDEFINE 1 randomized 3,417 adults.

Use only for the defined 68-week phase 3a trial in adults without diabetes.

Garvey et al., 2025

C-02

Estimated mean weight change was −20.4% with CagriSema and −3.0% with placebo.

Preserve the treatment-policy estimand and week-68 context.

REDEFINE 1 paper

C-03

CagriSema and cagrilintide are not FDA-approved U.S. drug products.

Recheck FDA records immediately before publication.

FDA enforcement record

C-04

Retatrutide remains investigational.

Trial milestones and sponsor announcements are not approved labeling.

TRIUMPH-1 registry

C-05

GLORY-1 randomized 610 Chinese adults.

Do not generalize the trial population beyond its enrollment criteria.

Ji et al., 2025

C-06

Week-48 weight change was −11.00%, −14.01%, and +0.30%.

Respect the two mazdutide groups, placebo group, and 48-week endpoint.

GLORY-1 paper

C-07

Mazdutide has no FDA-approved U.S. product in the cited record.

FDA described named online products as unapproved new drugs; do not imply a universal product-quality finding.

FDA warning letter

C-08

A trial result does not establish FDA approval.

Approval is a separate review of a defined application and product.

FDA approval process

C-09

A trial does not authenticate an unrelated product.

Ingredient name alone does not establish formulation, sterility, strength, manufacturer, or equivalence.

FDA product-risk context

Primary and official sources

Garvey et al., 2025

REDEFINE 1 randomized phase 3a trial. PubMed →

ClinicalTrials.gov NCT05929066

TRIUMPH-1 retatrutide registry record. Registry →

Ji et al., 2025

GLORY-1 phase 3 mazdutide trial. PubMed →

FDA warning letters

Official records concerning cagrilintide, mazdutide, and related online products. 2024 letter → · 2026 letter →

FDA development and product-quality explainers

Approval process → · Compounded-drug risks →

Publication boundary: This source log and article passed a separate source-verification pass on July 18, 2026. The monitor may discover a change, but only a separately verified commit may alter factual copy, and newsletter publication remains manual.