Lilly's Zepbound (tirzepatide) achieved additional 6.7% weight loss following a 36-week open-label lead-in period, for a total mean weight loss of 26.0% from study entry over 88 weeks

 People who were randomized to placebo following the lead-in period experienced mean weight regain of 14.8% at 88 weeks, indicating Zepbound led to sustained weight loss compared to placebo

Full results from the SURMOUNT-4 study were published in The Journal of the American Medical Association

INDIANAPOLIS, Dec. 11, 2023 -- Detailed results from SURMOUNT-4, which showed Zepbound™ (tirzepatide) injection achieved superior mean percent change in body weight compared to placebo in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes, were published in The Journal of the American Medical Association (JAMA). Zepbound met the primary endpoint of mean percent change in body weight, and all key secondary endpoints for both estimandsi,ii, compared to placebo 52 weeks after randomization.

Study Design

SURMOUNT-4, a phase 3 study evaluating the safety and efficacy of Zepbound compared to placebo, had two periods.

Lead-in period: 36-week open-label period during which participants took Zepbound at the maximum tolerated dose.

Double-blind treatment period: 52-week treatment period during which participants were randomized to either continue on Zepbound or switch to placebo.

SURMOUNT-4 utilized a maximum tolerated dose of 10 mg or 15 mg once-weekly. The starting dose of 2.5 mg Zepbound was increased by 2.5 mg every four weeks until maximum tolerated dose was achieved. Participants who tolerated 15 mg continued on 15 mg as their maximum tolerated dose. Participants who tolerated 10 mg but did not tolerate 15 mg continued on 10 mg as their maximum tolerated dose.

"Patients, providers and the public do not always understand obesity is a chronic disease that often requires ongoing treatment, which can mean that treatment is stopped once weight goals are met," said Jeff Emmick, MD, Ph.D., senior vice president, product development, Lilly. "However, studies like SURMOUNT-4 show that continued therapy can help people living with obesity maintain their weight loss."... Lilly's Press Release - Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity - The SURMOUNT-4 Randomized Clinical Trial in The Journal of the American Medical Association (JAMA) - A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss (SURMOUNT-4) - 

OrsoBio Announces $60M Series A Financing to Advance Metabolic Portfolio for the Treatment of Obesity and Associated Disorders

OrsoBio Announces $60M Series A Financing to Advance Metabolic Portfolio for the Treatment of Obesity and Associated Disorders

Co-led by Longitude Capital and Enavate Sciences, with Significant Participation by Existing Investors Samsara BioCapital and NuevaBio

MENLO PARK, Calif. – November 7, 2023 – OrsoBio, Inc. (“OrsoBio” or “the Company”), a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced the successful completion of a $60 million Series A financing, bringing the total capital raised by the Company to $97 million.

[...]

OrsoBio will utilize the Series A funding to advance the development of its innovative portfolio of four programs focused on obesity and associated metabolic disorders.

Mitochondrial protonophore portfolio: Clinical development of the liver-targeted protonophore TLC-6740 through a Phase 1b study to establish proof of concept and initiation of a Phase 2a study in patients living with obesity, and advancement of IND-enabling activities for TLC-1235, a controlled-release mitochondrial protonophore.

• TLC-3595 (ACC2 inhibitor): Completion of a Phase 2a study in patients with insulin resistance/diabetes (NCT05665751) and preparations for a Phase 2b study.
• TLC-2716 (LXR inverse agonist): Completion of a Phase 2a study in patients with severe hypertriglyceridemia (SHTG)/nonalcoholic steatohepatitis (NASH) and groundwork for a Phase 2b program.
• ACMSD inhibitor (aminocarboxymuconate semialdehyde decarboxylase inhibitor): Selection of a development candidate for potential treatment of metabolic and inflammatory liver and kidney disorders and advancement of IND-enabling activities...OrsoBio's Press Release.

PROLOR Biotech : Positive Results of Its Obesity/Diabetes Drug Candidate in Preclinical Weight Loss Study

April 17, 2012 - PROLOR Biotech, Inc. (NYSE Amex: PBTH) reported positive preclinical results from an animal study of its long-acting obesity/Type II diabetes drug candidate MOD-6030. The study was designed to measure the potential therapeutic effect of MOD-6030 injected once weekly as measured by weight loss, reduction in food intake, glycemic control and cholesterol levels. The study results will be presented at GTC's 5th Diabetes Drug Discovery and Development Conference on April 19, 2012 in Boston, MA.

In the study, MOD-6030 administered to diet-induced obese (DIO) mice once weekly over a 30-day period demonstrated significant efficacy in reducing weight, lowering blood glucose levels, increasing insulin sensitivity and reducing cholesterol levels as compared to a group that received placebo. Animals in the placebo group showed minimal changes in the study parameters, while the animals receiving MOD-6030 achieved on average a 28% reduction in weight, a 29% reduction in food intake, a 19% reduction in blood glucose levels and a 57% reduction in cholesterol levels. Body composition analysis showed that the weight loss resulted specifically from reductions in body fat... [PDF] PROLOR Biotech's Press Release -

LATITUDE Pharmaceuticals : Stable Liquid Glucagon Formulation

April 03, 2012 - LATITUDE Pharmaceuticals, Inc. (LPI) announced that its scientists have developed the first ever, ready-to-inject, stable liquid glucagon formulation (Nano-G). A glucagon formulation with these properties had been a highly sought after Holy Grail of drug developers for decades.

Currently, glucagon is indicated for emergency treatment of insulin-induced hypoglycemia and as a diagnostic aid for radiological examinations. Researchers have long been interested in evaluating glucagon for hypoglycemia prevention, the bi-hormonal insulin/glucagon pump and the treatment of obesity but have been thwarted by the absence of a stable injectable glucagon formulation.

Glucagon is a notoriously insoluble and unstable molecule and is therefore provided as a dried powder. Before use, the glucagon is dissolved in an acid solution by following a cumbersome, eight-step procedure that becomes an outsized task during life-threatening hypoglycemia.

Nano-G is a pH-neutral, isotonic, detergent-free, aqueous formulation that contains only FDA-approved injectable ingredients. Results from rigorous 6-month real-time and accelerated ICH stability testing predict a 2-yr shelf-life. Nano-G is also stable at body temperature, making it highly suitable for subcutaneous infusion pump delivery.

“Nano-G fulfills the long overdue need for a rapidly self-administered, auto-injector delivered glucagon for hypoglycemia rescue and is the missing piece needed for the bi-hormonal pump and novel combination therapies for obesity... LATITUDE Pharmaceuticals' Press Release -

AMA : Free ‘Weigh What Matters’ App to Help People Achieve Healthier Lifestyles

Jan. 30, 2012 – Many Americans resolved to become healthier in the new year, but are having trouble monitoring their progress to achieve their goals. Now there's an app for that. The American Medical Association (AMA) released a free app today to help patients improve their overall health as part of the AMA Healthier Life Steps program, which promotes healthy choices and healthy lives.

"Every January, Americans implement New Year's resolutions that involve healthy eating and increased physical activity," said AMA President Peter W. Carmel, M.D. "This new app encourages people to work with their physicians to set healthy goals, and it allows users to track their progress and accomplish their goals."

The Weigh What Matters app is free, easy to use and encourages users to consult with their physician to establish personal health goals for three categories: weight, eating and activity. Once goals are established, users can track their weight, physical activity and nutrition with daily entries. It also calculates a user's Body Mass Index (BMI) and provides a mechanism to view progress reports and email them to the user's physician.

"The AMA Healthier Life Steps program offers tools and information to help physicians and patients work together to promote longer, healthier lives," said Dr. Carmel. "Physicians and their staff can use this new app as a resource to work with patients to address challenging behavioral changes."...American Medical Association's Press Release -