Trials, Methodology Guides
Trial Methodology Guides
Plain-language primers on how to interpret peptide clinical-trial records, distinguish endpoint quality, and read a regulatory dossier without losing the thread.
- 10 min
How Clinical Trials Work for Peptide Therapeutics
Covers the full clinical trial pipeline for peptide therapeutics: preclinical work, IND filing, Phase 1 through Phase 4, surrogate versus hard endpoints, and how FDA and EMA authorisations differ from trial registration.
Read guide - 11 min
Phase 1 / 2 / 3 / 4 Trials Explained for Peptide Therapeutics
Detailed guide to Phase 0 through Phase 4 clinical trials as applied to peptide therapeutics. Covers microdosing, adaptive and basket designs, sample-size expectations per phase, and how to interpret primary endpoints, hazard ratios, and confidence intervals in Phase 3 result tables.
Read guide - 10 min
Primary vs Secondary vs Exploratory Endpoints
Explains the statistical and regulatory logic behind endpoint hierarchy in clinical trials, covering primary, key secondary, secondary, exploratory, and post-hoc outcomes. Details common endpoint types in peptide metabolic trials: HbA1c, percent body weight loss, MACE, patient-reported outcomes, and the hard-versus-surrogate distinction.
Read guide - 11 min
Bias, Blinding, and Why Double-Blind Phase III Matters
Covers the hierarchy of trial evidence, the main categories of bias (selection, measurement, recall, attrition, reporting), blinding methods including double-dummy, allocation concealment, intention-to-treat versus per-protocol analysis, and how to evaluate sponsor-funded trials.
Read guide - 9 min
How to Read a ClinicalTrials.gov Listing
Explains what ClinicalTrials.gov is, how its data fields map to the drug-development process, how to find peptide trials by intervention name, what study status categories mean, and how the registry record relates to eventual journal publication.
Read guide - 12 min
Endpoints in Metabolic Peptide Trials: HbA1c, MACE, Percent Body Weight
A detailed examination of the primary endpoints used in pivotal metabolic peptide trials: HbA1c reduction in T2DM, MACE in cardiovascular outcomes trials, percent body weight loss in obesity, and how time-to-event versus difference-in-means reporting methods are applied. Uses LEADER, SUSTAIN-6, SELECT, STEP-1, and SURPASS-2 as illustrative examples.
Read guide - 13 min
Weight Loss Injections: How the Pivotal Trials Were Designed
A trial-design guide to weight loss injections. Explains the standard architecture of a phase 3 weight-management trial, why the diet and activity programme in both arms changes how the result should be read, how titration schedules and trial duration shape the headline percentage, what the STEP 4 and SURMOUNT-4 withdrawal designs established about durability, why blinding is imperfect when side effects are perceptible, and an eight-question checklist for appraising any trial in this literature.
Read guide