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This week on On The Pen, we break down a rare FDA walk-back on GLP-1 safety labeling, major pharma signals coming out of JPM 2026, and the growing tension between patient access and legislative efforts that could restrict compounding. We discuss what these developments actually mean for patients, why access—not innovation alone—will determine the future of obesity medicine, and how the OTP community continues to play a critical role in shaping this landscape.

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This episode opens the year with one of the most consequential—and complicated—weeks in GLP-1 obesity medicine.

We break down three stories that, taken together, reveal why patients are increasingly reading past headlines and demanding accountability from the industry.

First, we examine early-phase trial data from Arrowhead Pharmaceuticals, after headlines claimed its experimental INHBE-targeting therapy “nearly doubled” the weight loss of Zepbound. We walk through what the data actually showed, why the comparison was misleading, how trial design and dosing matter, and why Phase 1 results should never be treated as superiority claims.

Next, we turn to a major access milestone: the official launch of oral Wegovy, the first FDA-approved GLP-1 pill for obesity from Novo Nordisk. We discuss how this pill differs from compounded oral semaglutide, why its pricing strategy is so disruptive, and what this launch means for people who have avoided injectable medications. We also explore how direct-to-consumer access, telehealth partnerships, and retail pharmacy distribution signal a broader shift in how obesity care is being delivered.

Finally, we address the most ironic—and uncomfortable—story of the week: manufacturing quality concerns involving branded Wegovy pens, reported to include biological particulate matter, at the same time Novo Nordisk continues a years-long public and legal campaign against compounded GLP-1 medications on safety grounds. We discuss FDA inspection history, the acquisition of Catalent, and why credibility depends on consistency—especially when millions of patients are paying close attention.

This episode isn’t anti-pharma or pharma-friendly. It’s patient-first.
And it asks a simple question: Who do we trust when science, marketing, access, and manufacturing all collide at once?

Episode Timestamps

00:00 — Why this first episode of 2026 matters
02:10 — Hair found in Wegovy pens and why patients notice hypocrisy
06:15 — Arrowhead trial headlines vs. what the data actually shows
11:40 — Why tirzepatide dosing and trial design matter
17:30 — What INHBE targeting may actually be good for (and what it’s not)
21:45 — Sponsor: SHED and access pathways for obesity care
25:10 — Oral Wegovy officially launches: what’s different this time
30:20 — How the Wegovy pill works and why bioavailability matters
35:40 — Pricing, telehealth, Costco, and direct-to-consumer access
41:50 — Why pills lower barriers for millions of patients
46:10 —

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Pharma Influence & Why Patient Voices Matter
Lobbying Power: Eli Lilly, Novo Nordisk, and Government Access
Why GLP-1 Medication Access Is at Risk
Introducing Sabina Hemi & the Mission of GLP Winner
Why Compounded GLP-1s Matter for Real Patients
The Federal “Safe Drugs” Bill: What It Claims vs What It Does
Why This Bill Raises Red Flags for Patients
What Real Compounding Safety Reform Would Look Like
How Compounding Pharmacies Are Actually Regulated Today
Prescription Reporting vs Patient Safety
Is This Bill About Safety or Litigation Data?
Dose Flexibility, Personalized Medicine, and Compounding
Florida SB 860: A Direct Threat to Compounded GLP-1s
Why Florida Compounding Impacts the Entire Country
Why Obesity Medications Are Being Singled Out
Active Pharmaceutical Ingredients (API): What Patients Should Know
FDA Oversight, the “Green List,” and State Overreach
Why Florida’s API & COA Requirements Don’t Add Up
FDA Inspection Backlogs & Impossible Compliance Standards
Branded Drug Safety Issues vs Compounding Scrutiny
Catalent, Novo Nordisk, and Manufacturing Concerns
Counterfeit Ozempic: The Overlooked Safety Crisis
Why Supply Chain Integrity Should Be the Priority
What Patients Can Do Right Now
Petitions, Advocacy, and Making Your Voice Heard
Florida Residents: Why Local Action Matters
Final Thoughts on Access, Power, and Patient Advocacy

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Retatrutide is years away from FDA approval and yet the fight over access, price, control of this medication is already well underway. That's what this podcast is going to be about today. There's well over a hundred thousand people by my estimates who are already on some form of this medication today. And that should tell you enough about how disruptive this molecule is and will be. It is a game changer among game changer. We've been talking about it for three years here at On The Pen, well before any of your favorite gym bros were talking about Retatrutide. We were talking about Reta, who tried Retatrutide here at On The Pen. And that's because we identified this triple agonist as a game changer among game changers. So This is going to be a very Retatrutide heavy episode, and so I hope you'll join us and stick with us if this is a topic you enjoy, because I think this is really going to effectively lay the groundwork for what accessibility to this medication will look like. So let's get into it.

Welcome to the On The Pen Podcast with your host, Dave Knapp. Welcome to the On The Pen, the weekly dose podcast. This is our weekly roundup in incretin memetic news. And frankly, there's no news that is bigger than Reta-Trutide news. Just find me any news that is bigger than the data that we got on Reta-Trutide. Now, we already did a video about the Triumph Phase II clinical trials that we got in osteoarthritis of the knee. You can go back and check out that video if you'd like more data. So we're not gonna super... rehash the data. We'll go over at a high level what the data showed us. We're not going to go over how the medicine works, because by now we all know that it's the triple agonist, right? If terzapatide was a dual agonist, GLP-GIP, Retatrutide is the triple agonist that adds to it a glucagon component, which is absolutely just shredding, shredding liver fat. It is absolutely revving up people's metabolism and showing a tremendous amount of weight loss.

So let's get into what the weight loss looked like in this first trial, because there are longer obesity trials where, where the primary outcome is the weight loss this was again a specific trial in measuring pain reduction in folks with osteoarthritis of the knee but check out these numbers these are placebo adjusted meaning it's taking the two percent out that people lost on placebo but looking at these numbers Folks on one milligram over forty eight weeks lost seventeen percent. They bumped up to four milligrams. Those folks lost twenty two percent. So right there a

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0:00 Welcome & today’s focus: Retatrutide and “chasing the biggest number”
1:11 On The Pen intro, live schedule (Mon/Wed/Fri) & housekeeping
2:10 How Dave first heard about retatrutide (work trip, early phase 1 data)
3:35 Flashback clip: early excitement about retatrutide phase 3 trials
4:40 Why this new retatrutide data feels different for obesity medicine
5:32 TRIUMPH-4 trial overview: obesity + knee osteoarthritis population
7:00 Headline results: 28.7% average weight loss, surgery-level efficacy
8:47 Breaking down weight loss by dose (9 mg vs 12 mg; 25–35% loss rates)
11:05 What “efficacy estimate” really means (race-track analogy)
13:28 Real-world view: treatment-regimen estimate (20–23.7%) vs trial ideal
15:40 Mechanism refresher: GIP, GLP-1, glucagon and why RETA differs from TIRZ
18:05 Side effects, dysesthesia/allodynia & who stopped treatment (BMI differences)
21:02 Why the lower doses matter & who actually needs 30% weight loss
24:15 From “just make the scale go down” to quality of weight loss & body composition
28:05 Future focus: health, longevity, and peptides beyond hitting goal weight
30:40 Viewer Q&A: combining RETA + TIRZ, amylin (eloralintide) combos & “talk to your doctor”
34:38 How retatrutide changes the next decade of obesity treatment conversations
37:22 News update: high-dose Wegovy 7.2 mg approval in the EU & US outlook
40:55 Orforglipron oral GLP-1: liver-signal concerns & fast-track FDA review
45:20 Why small-molecule oral GLP-1s aren’t the same as injectable peptides
48:40 New topic: Indiana “Safe Drug Act of 2025” and why Dave is concerned
51:02 Production caps, “essentially a copy” language & shifting power from prescribers to FDA
54:28 How the bill undermines personalization while ignoring real safety tools
57:05 Safety theater vs real safeguards: API sourcing, sterility & adverse-event reporting
59:45 Who actually gets hit: compliant 503A/503B compounders vs existing bad actors
1:02:05 Call to action: petition at otplinks.com & why patient voices matter
1:05:10 Change.org impact, media attention & centering the patient perspective
1:07:30 Final Q&A, subscribe, obesity.news email list & closing thanks

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Episode Timeline & Main Topics

00:00 — Opening & Community Update
• First week doing the podcast fully live thanks to the On The Pen community
• Overview of why this week’s news is a major turning point in obesity medicine

02:30 — Introducing the “One-and-Done” Obesity Drug (Wave Life Sciences)
• WVE-007 early data drops
• Why this therapy is unlike GLP-1s or any nutrient-stimulated hormone
• Fat loss results and lean-mass increase

06:30 — How Wave-007 Works: INHBE Gene Silencing
• Mechanism behind visceral fat reduction
• Why this shifts the field toward “quality of weight loss”

09:15 — Why Lean-Mass Preservation Matters
• Current GLP-1 medications and muscle loss
• Why women dominate trial enrollment and the larger implications
• Medicare patients and the coming wave of GLP-1 coverage

13:45 — The Future of Maintenance Therapies
• Fractyl Health Revita results
• Lilly’s orforglipron maintenance design
• Why “holding the line” after GLP-1 therapy is the next major category

17:30 — Amylin Agonists: Cagrelintide vs. Eloralintide
• Novo’s delays and the strategy behind them
• Lilly’s surprising phase 2 results (up to 20% weight loss)
• Combination therapies with tirzepatide or retatrutide

22:30 — FDA Pipeline Acceleration
• Potential removal of traditional phase 3 trials
• How this speeds up the arrival of next-generation therapies

24:15 — Oral GLP-1 Small Molecules (Structure Therapeutics)
• Alaniglipron data and the stock surge
• Comparisons to orforglipron and past failures like denuglipron
• Why Dave remains skeptical

28:40 — Sponsor Break: Shed & Shapa
• Access, coaching, and patient support
• Using a numberless scale to build a healthier relationship with weight tracking

31:10 — Counterfeit Ozempic Warning
• New fake lot discovered in U.S. pharmacies
• How to identify counterfeit pens
• Why this should be a national headline
• The broader question of drug supply-chain vulnerability

36:00 — Closing Thoughts on the Future of Obesity Medicine
• Moving from “more weight loss” to “better weight loss”
• Why the field is closer than ever to reshaping obesity as a disease
• Gratitude for the community making full-time coverage possible

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Topics We Cover:

00:00 – New data from Harvard/Mass General may classify nearly 70% of adults as having obesity
03:00 – A new oral triple agonist shows record-setting absorption rates
07:00 – Fractal Health’s Revita procedure: weight maintenance after stopping GLP-1s
12:00 – Zepbound vial prices drop (full breakdown by dose)
16:00 – Dave’s personal experience switching off Mounjaro and intense hunger return
22:00 – Novo Nordisk’s EVOKE/EVOKE+ Alzheimer’s trial: what the data really means
29:00 – Why GLP-1 neurological research is just getting started
33:00 – Updates on access, partners, and major news coming soon for Medicare patients

If you’re on Wegovy, Mounjaro, Zepbound, Saxenda, Trulicity, or compounded versions, this episode gives you the insight and context you need to have more competent and confident conversations with your doctor.

Bullet Point Summary of the Podcast Episode

1. New Obesity Measurement Data (Harvard/Mass General Study)

Harvard and Mass General propose adding waist circumference to BMI to better diagnose obesity.

Traditional BMI misses key factors like muscle mass and body composition.

Using the updated measure, Americans classified as obese jumps from ~43% to almost 69%.

This means 7 out of 10 U.S. adults would now qualify as having the disease of obesity.

Dave notes this validates many people who “feel” metabolically unwell despite a “normal” BMI.

Reinforces his claim that “most people should be talking to their doctors about GLP-1s.”

1. New Oral Triple Agonist (Ascletis – ASC41/ASC? Molecule)

From Ascletis (A-S-C-L-E-T-I-S), developing an oral triple agonist targeting:

GLP-1

GIP

Glucagon

Similar in mechanism to retatrutide, expected around 2027.

Preclinical (animal) data show stunning results:

Oral bioavailability of 4.2%

9× higher than tirzepatide

30× higher than oral semaglutide

6× higher than oral retatrutide

57× greater drug exposure than oral retatrutide

Half-life ~56 hours

Stronger receptor activation than retatrutide in vitro

Suggests potential for the first powerful oral triple agonist—worth watching.

️ 3. Discussion of the Gray Market / TikTok Experience

Dave briefly recounts losing his TikTok account and landing in an algorithm filled with teenagers promoting gray-market “retatrutide.”

Expresses concern over unregulated peptide sales, especially to minors.

1. F

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