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Amgen Weighs In to Chase Rival Obesity Drugs From Novo Nordisk and Eli Lilly
Amgen Weighs In to Chase Rival Obesity Drugs From Novo Nordisk and Eli Lilly

An Amgen drug that employs two different mechanisms to lead to weight loss has early-stage clinical data showing durable effects, laying the groundwork for a Phase 2 test as the pharmaceutical giant continues to chase rival obesity drugs from Novo Nordisk and Eli Lilly.
Patients in the Phase 1 study were randomly assigned to receive the experimental Amgen drug, code-named AMG 133, or a placebo, either as a single dose or multiple ascending doses given as a subcutaneous injection every four weeks. Those participants were obese but did not have other medical conditions, including diabetes.
In the 26 patients who received multiple ascending doses, Amgen reported that the drug led to an average of 7.2% weight loss at the lowest dose and an average 15.5% weight loss at the highest dose by day 85. The company added that the weight loss was maintained at the highest doses for up to 150 days following the third and final administration of the drug. Data from three of the six multiple dose-ascending cohorts were reported. The other three were not included due to data analysis that is still ongoing, Amgen said in an investor presentation Monday.
Amgen presented the preliminary data over the weekend during the 20th World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease Hybrid Conference. With the encouraging results, the Thousand Oaks, California-based pharmaceutical giant said Monday that it plans to start a Phase 2 study in early 2023.
AMG 133 is an antibody-peptide conjugate designed with one part that activates a target called GLP-1 and the other that blocks a different target called GIPR. In preclinical research, Amgen reported this dual approach led to weight loss as well as improvement in other metabolic measures.
“AMG 133 was designed based on preclinical and human genetic data that strongly suggest GIPR inhibition as a strategy for weight loss, especially in combination with GLP-1 agonism,” David Resse, Amgen’s executive vice president of research and development said in a prepared statement. “We are encouraged by these Phase 1 results with once-monthly dosing of AMG 133, specifically, the degree, rate and durability of the weight loss.”
In the Phase 1 study, the most common side effects reported were nausea and vomiting. Amgen characterized these side effects as mild and transient. These problems were associated with the first dose and most of them resolved within 48 hours, the company said.
With AMG 133, Amgen is chasing Novo Nordisk’s semaglutide, a GLP-1-activating drug that won its first FDA approval in 2017 for treating type 2 diabetes. The once-weekly injectable molecule is marketed as Ozempic in that indication. Last year, the FDA approved semaglutide for chronic weight management, where the drug is marketed as Wegovy. In the four 68-week pivotal studies supporting Wegovy’s regulatory submission, treatment led to an average 12.4% weight loss.
Eli Lilly is also looking to add weight loss to the label of its drug, Mounjaro, which was approved earlier this year for treating type 2 diabetes. Mounjaro is a peptide drug designed to activate both GIP and GLP-1. Clinical research in type 2 diabetes showed that the drug also led to weight loss. In its report of third quarter financial results last month, Lilly said it planned to initiate a rolling submission for the drug in obesity this year, completing the application soon after the second of two Phase 3 tests has data, which are expected in April 2023.
Comparing weight loss data across clinical trials is tricky, as these drugs were not tested head to head. But despite trailing the regulatory progress its rivals, Amgen hopes AMG 133’s once-a-month dosing provides patient convenience and a competitive edge versus the once-weekly dosing of Wegovy and Mounjaro.
In a Monday research note, William Blair analyst Matt Phipps wrote that weight reductions of around 15% after three doses of AMG 133 compares favorably with the Phase 3 results posted by the Novo Nordisk and Lilly drugs at 12 weeks, with the caveat that Amgen’s results are from a smaller group of patients. Nevertheless, Phipps characterized the rate and magnitude of body weight reductions as “impressive.” He added that the pharmacokinetic and pharmacodynamic data support less frequent dosing than other drugs in the class with the potential to go beyond every four week dosing in a maintenance setting.
However, Phipps said the lack of biomarker data leave many questions about the role of blocking GIPR versus activating it the way that Lilly’s drug does. William Blair has previously noted the potential for GIPR antagonism to affect bone mineral density and bone strength.
Photo: Patrick T. Fallon/Bloomberg, via Getty Images

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DTC Metabolic Tracker Company To Expand Personalized Nutrition Guidance With $62M
DTC Metabolic Tracker Company To Expand Personalized Nutrition Guidance With $62M

Users breathe into the Lumen device in order to get a reading on their metabolism. Based on the results, the connected app will give users a recommendation to follow a low-carb diet that day, a high-carb diet or somewhere in-between.
Wellness and fitness company Lumen announced Thursday that it aims to bring its metabolism tracking platform to more consumers in the U.S. and globally after raking in $62 million in Series B funding.
The Tel Aviv, Israel-based startup was founded in 2014 by twin sisters Michal and Merav Mor when they were training for the Ironman, a triathlon consisting of swimming, biking and running. They created a peer-reviewed handheld device that measures users’ metabolism through breath and connects to an app that helps track goals and provides nutrition coaching. The product is sold directly to consumers through the company’s website.
“Lumen understands the impact of each person’s nutrition, exercise, sleep, and stress on their metabolism by simply breathing into the device,” Michal Mor, co-founder and head of science for product for Lumen, wrote in an email. “Up until now, this was a process that was only available in hospitals or clinics and consisted of a 45-minute lab test.”
Users breath into the device each morning, which measures CO2 to determine the body’s source for energy that day: fats or carbs. It gives a score from one to five, with one meaning the user is almost entirely burning fat and five meaning the user is almost entirely burning carbs. Lumen will then give a recommendation for the user’s food intake, which could be a low-carb day, a high-carb day or somewhere in between.
The $62 million funding round was led by Pitango Venture Capital, and included participation from Hanwha Group and Resolute Ventures. In total, the wellness company has raised $77 million.
With the financing, Lumen hopes to reach more consumers, expand its personalized nutrition and lifestyle coaching services and gain more research partnerships with academic institutions. In the past year, the company has conducted several studies with universities, including Purdue University’s Whistler Center for Carbohydrate Research, University of Toronto’s Faculty of Kinesiology and Physical Education and ARU Cambridge, Mor said.
Additionally, an October study done with Tel Aviv Sourasky Medical Center found that 12-week prediabetic Lumen users lowered their Hb1c levels, and achieved an average weight loss of 13 pounds and a 3% body fat reduction.
Lumen offers three pricing options for its product: $249 for six months, $399 for 12 months or $699 for 12 months with personalized support from nutritionists. The device is not currently FDA approved, as it is not a medical device for diagnosing or treating conditions. However, the company hopes to provide services in the future for several medical conditions and illnesses, for which it will seek FDA approval, according to its website.
There’s a need for the company’s services. The metabolic health crisis is responsible for $464 billion in annual healthcare costs and affects eight out of 10 American adults, according to ScienceDaily.
“Our goal has always been to make metabolism measurement accessible to global communities because it’s the starting point to unlock your health and prevent major illnesses,” Mor said. “Lumen’s tracker helps users to improve their metabolic health, by optimizing nutrition, sleep, fitness regimes and more. Taking specific health conditions into account, like menopause and diabetes, helps us target our prime metabolic health.”
Lumen is the only company measuring metabolism through breath with a handheld device, Mor declared. However, for people diagnosed with a metabolic disease like diabetes, companies such as Dexcom, Medtronic and Abbott offer continuous glucose monitoring devices available by prescription.
Photo: Lumen

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