GLP‑1 news from 2018
10 dated, sourced GLP-1 developments from 2018: approvals, trial results, prices, lawsuits, compounding and culture.
- Science
Phase 2 results for diabetes drug LY3298176 published in The Lancet
A Phase 2 trial of the experimental dual GIP/GLP-1 drug LY3298176 in type 2 diabetes was published Oct. 4, 2018 in The Lancet. Earlier first-in-human testing described in Molecular Metabolism found that 10 mg and 15 mg doses lowered fasting glucose versus placebo by 49.12 mg/dL and 43.15 mg/dL, and that weight fell more than with placebo; the most common side effects were gastrointestinal.
- Science
Lilly paper describes LY3298176, the dual GIP and GLP-1 drug now called tirzepatide
On October 3, 2018, Eli Lilly researchers published a paper in Molecular Metabolism describing LY3298176, a dual GIP and GLP-1 receptor agonist that is now known as tirzepatide. The paper reported binding constants of 0.135 nM at the GIP receptor and 4.23 nM at the GLP-1 receptor, along with a three-part Phase 1 program in which 142 people received at least one dose. In the diabetes cohort, the 10 mg and 15 mg doses lowered fasting blood sugar against placebo by 49.12 mg/dL and 43.15 mg/dL, and the most frequent side effects were gastrointestinal.
- Business
Albiglutide cut cardiovascular events in Harmony Outcomes, but the drug was already off the market
The Harmony Outcomes trial found that once-weekly albiglutide reduced the combined risk of cardiovascular death, heart attack or stroke by about 22% in 9,463 adults with type 2 diabetes and cardiovascular disease, compared with placebo. The results were published in the Lancet in October 2018, after GlaxoSmithKline had already stopped selling the drug. European regulators formally withdrew albiglutide's marketing authorization on October 29, 2018, at the company's request.
- Culture
Novo Nordisk turns 1970s pop hit 'Magic' into Ozempic jingle in first TV ad
Novo Nordisk launched its first direct-to-consumer TV campaign for Ozempic in the week of July 30, 2018, licensing Pilot's 1970s hit "Magic" and rewriting the refrain as "Oh, oh, oh, Ozempic". The jingle repeats several times in the 90-second spot, which also tells viewers that average weight loss in a recent study was up to 12 pounds and that the drug carries no increased risk of major cardiovascular events. Analysts projected Ozempic sales of more than $2.2 billion by 2022.
- Research and trials
Novo Nordisk began testing semaglutide 2.4 mg for weight loss in 2018, work that led to Wegovy
Novo Nordisk launched a phase 3 program in June 2018 to test semaglutide 2.4 mg for chronic weight management. That program produced the data behind Wegovy, which the FDA approved for adults with obesity on June 4, 2021, after a 68-week trial reported significant and maintained weight loss.
- Regulation
Japan cleared Ozempic for type 2 diabetes in March 2018, with Rybelsus tablets following in 2020
Japan's regulator approved Ozempic Subcutaneous Injection 2 mg for type 2 diabetes in March 2018, and Rybelsus 3 mg tablets for the same condition in June 2020. Both contain semaglutide, the active ingredient later approved in Japan as Wegovy for obesity in 2023.
- Regulation
European Commission authorizes Ozempic for type 2 diabetes across the EU
The European Commission granted Ozempic a marketing authorization valid throughout the European Union on 8 February 2018. The clearance covers semaglutide for adults with type 2 diabetes whose blood sugar is not controlled well enough, and rests on five trials in more than 4,000 patients plus a heart-risk study in more than 3,000.
- Research and trials
Semaglutide beats dulaglutide on blood sugar and weight in head-to-head trial
In a 1,201-patient trial published Feb. 1, 2018, once-weekly semaglutide lowered HbA1c by 1.8 percentage points versus 1.4 with dulaglutide at the highest doses tested, and cut weight by 6.5 kg versus 3.0 kg over 40 weeks. Lower doses showed the same pattern. The trial was funded by Novo Nordisk.
- Business
Ozempic reached US pharmacies in 2018, months after its December 2017 FDA approval
Ozempic (semaglutide) was approved by the FDA on December 5, 2017 for type 2 diabetes and became commercially available to US patients in 2018. The drug is now approved for type 2 diabetes, cardiovascular risk reduction and worsening kidney disease, and the same molecule later launched at weight-management doses as Wegovy in 2021.
- Business
Lilly licensed orforglipron, now approved as Foundayo, from Chugai in 2018
Eli Lilly licensed orforglipron, the compound now sold as the obesity pill Foundayo, from Japan's Chugai Pharmaceutical Co., Ltd. in 2018, Lilly says in its FDA approval release. The drug was approved April 1, 2026 for adults with obesity or overweight with weight-related medical problems, with shipping set to begin April 6.