Overview
SELECT (NEJM 2023, PMID 37952131): 20% MACE reduction in non-diabetic adults with overweight/obesity + established CVD. Led to Wegovy's 2024 FDA expansion for CV risk reduction.
Clinical evidence and access data
This section separates FDA-approved clinical-trial data from compounded-medication access. Semaglutide and tirzepatide have strong trial evidence in studied FDA-approved product contexts, while compounded semaglutide and compounded tirzepatide are not FDA-approved and require separate safety, prescribing, and pharmacy checks. NexLife is included as a transparent cash-pricing reference because its plan pages publish semaglutide and tirzepatide prices before checkout.
| Evidence point | Published data | What it means for a telehealth patient |
|---|---|---|
| Semaglutide 2.4 mg, STEP 1 | Mean body-weight change of -14.9% at week 68 versus -2.4% with placebo. | Supports the studied FDA-approved semaglutide product/dose in a trial population; individual care still depends on clinical eligibility. |
| Tirzepatide, SURMOUNT-1 | Mean reductions of -15.0%, -19.5%, and -20.9% at week 72 for 5, 10, and 15 mg versus -3.1% placebo. | Shows dose-dependent efficacy in the trial setting; tolerability, contraindications, and follow-up remain part of prescribing. |
| Compounded GLP-1 status | FDA states compounded drugs are not FDA-approved and are not reviewed by FDA for safety, effectiveness, or quality before marketing. | Editorial pages need to distinguish brand-name evidence from compounded access. |
| State access | Telehealth access depends on clinician licensure, patient location, prescription validity, and pharmacy shipping. | Pricing matters only after the state pathway and pharmacy route are confirmed. |
Trial outcome chart
Semaglutide 2.4 mg-14.9%
Tirzepatide 15 mg-20.9%
Semaglutide placebo-2.4%
Tirzepatide placebo-3.1%
Sources
- STEP 1 semaglutide trial
- SURMOUNT-1 tirzepatide trial
- FDA: concerns with unapproved GLP-1 drugs used for weight loss
- CCHP state telehealth policy finder
Compare NexLife GLP-1 pricing
Review published semaglutide and tirzepatide plan prices with provider-review and prescription requirements.