Research library
STEP 1
- Product studied
- semaglutide 2.4 mg weekly (Wegovy dose) — an FDA-approved product, not a compounded formulation
- Design
- Randomized, double-blind, placebo-controlled; ~1,960 adults with overweight or obesity without diabetes; 68 weeks
- Headline finding
- Mean weight loss of roughly 15% of body weight with semaglutide 2.4 mg plus lifestyle intervention versus ~2.4% with placebo; gastrointestinal effects were the most common adverse events.
- Citations
- DOI / PMID / NCT to be confirmed and added at medical review — identifiers are never printed from memory
- Applicability
- Results apply to the trialed FDA-approved product and doses; they do not establish outcomes for compounded, microdose, oral, ODT, or sublingual formulations.
SURMOUNT-1
- Product studied
- tirzepatide 5/10/15 mg weekly (Zepbound doses) — an FDA-approved product, not a compounded formulation
- Design
- Randomized, double-blind, placebo-controlled; ~2,540 adults with obesity without diabetes; 72 weeks
- Headline finding
- Dose-dependent mean weight loss reaching roughly 20–21% at the highest dose versus ~3% with placebo; gastrointestinal events most common, typically during dose escalation.
- Citations
- DOI / PMID / NCT to be confirmed and added at medical review — identifiers are never printed from memory
- Applicability
- Results apply to the trialed FDA-approved product and doses; they do not establish outcomes for compounded, microdose, oral, ODT, or sublingual formulations.
SELECT
- Product studied
- semaglutide 2.4 mg weekly — an FDA-approved product, not a compounded formulation
- Design
- Randomized, double-blind, placebo-controlled cardiovascular-outcomes trial; ~17,600 adults with established cardiovascular disease and overweight or obesity, without diabetes; multi-year follow-up
- Headline finding
- Approximately a 20% relative reduction in major adverse cardiovascular events (cardiovascular death, nonfatal MI, nonfatal stroke) versus placebo.
- Citations
- DOI / PMID / NCT to be confirmed and added at medical review — identifiers are never printed from memory
- Applicability
- Results apply to the trialed FDA-approved product and doses; they do not establish outcomes for compounded, microdose, oral, ODT, or sublingual formulations.
SURMOUNT-4
- Product studied
- tirzepatide, maximum tolerated dose — an FDA-approved product, not a compounded formulation
- Design
- Randomized-withdrawal design: open-label tirzepatide lead-in, then randomization to continued tirzepatide or placebo; 88 weeks total
- Headline finding
- Continuing tirzepatide produced further weight loss after the lead-in, while switching to placebo led to substantial regain of lost weight — central evidence on discontinuation and weight regain.
- Citations
- DOI / PMID / NCT to be confirmed and added at medical review — identifiers are never printed from memory
- Applicability
- Results apply to the trialed FDA-approved product and doses; they do not establish outcomes for compounded, microdose, oral, ODT, or sublingual formulations.
SURMOUNT-5
- Product studied
- tirzepatide vs semaglutide, head-to-head — an FDA-approved product, not a compounded formulation
- Design
- Randomized, open-label; adults with obesity without diabetes; 72 weeks; funded by Eli Lilly
- Headline finding
- Tirzepatide produced greater mean weight loss than semaglutide 2.4 mg (roughly 20% versus 14%), with broadly similar gastrointestinal adverse-event profiles; the open-label design and sponsor funding are relevant limitations.
- Citations
- DOI / PMID / NCT to be confirmed and added at medical review — identifiers are never printed from memory
- Applicability
- Results apply to the trialed FDA-approved product and doses; they do not establish outcomes for compounded, microdose, oral, ODT, or sublingual formulations.
Reported weight-loss outcomes across pivotal trials
FDA-approved injectable products at studied doses. These outcomes do not transfer to compounded, microdose, or oral/sublingual formulations. Values pending citation confirmation at medical review.
View chart data as a table
| Trial & product | Mean weight reduction | Duration |
|---|---|---|
| STEP 1 — semaglutide 2.4mg | 14.9% | 68 weeks |
| SURMOUNT-1 — tirzepatide 15mg | 20.9% | 72 weeks |
| SURMOUNT-1 — tirzepatide 10mg | 19.5% | 72 weeks |
| SURMOUNT-5 — tirzepatide (h2h) | 20.2% | 72 weeks |
| SURMOUNT-5 — semaglutide (h2h) | 13.7% | 72 weeks |
These are widely reported headline figures from the pivotal trials of the FDA-approved injectable products at their studied doses, shown for scientific context and pending medical-reviewer confirmation of each value with its DOI/PMID/NCT. They are not evidence for any compounded preparation, any sub-therapeutic "microdose," or any oral/sublingual route. Percentages are placebo-subtracted or total means as reported and will be finalized with citations at review.
Planned coverage
Remaining STEP and SURMOUNT trials; SUSTAIN and SURPASS diabetes programs; PIONEER and OASIS oral-semaglutide programs; FLOW, SUMMIT, SURMOUNT-OSA, and ESSENCE outcomes trials; discontinuation and weight-regain meta-analyses; body-composition, sarcopenia, and frailty evidence; compounded-product real-world studies with funding and design disclosures; and research-only pages for investigational agents (retatrutide, CagriSema, cagrilintide, orforglipron, survodutide, mazdutide, amycretin). Investigational agents receive no purchase, provider, ranking, compounding, or dosing content — retatrutide and cagrilintide are not FDA approved and are not lawfully available as compounded treatments.