According to phase 3 data, treatment with Tirzepatide was associated with a significant weight loss for obese and overweight adults.
Tirepatide is a once weekly dual glucose-dependent insulinotrop polypeptide (gip) and glucagon-like peptide-1 (GLP-1) receptor agonist, which integrates the effects of both incretins into a single molecule. It is assumed that GIP adds the effects of GLP-1 receptor agonists.
The Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Surmount-1 Trial (Clinicaltrials.gov Identifier: NCT04184622) Evaluated the Efficacy and Safety of Tirepatide as An Adjunct to A Reduced Calorie Diet and Increasical Activity in 2539 Adults Without Type 2 Diabetes Who Have Obesity, Or Are Overweight With at Least 1 of the Following Comorbidities: Hypera pressure, dyslipaemia, obstructive sleep apnea or cardiovascular diseases. The average basic body weight of the patient was 105 kg.
The patient was assigned to the patient 1: 1: 1: 1 to either receive 5 mg, 10 mg, 15 mg or placebo -subkutan once a week for 72 weeks. The co -endpoints of the study were the percentage change compared to the body weight and percentage of patients, which achieved at least 5% body weight reduction in week 72.
The results of the efficiency estimate showed that treatment with Tirepatide in week 72 compared to placebo was associated with the following reductions in body weight:
- Average reduction in body weight: 16% (16 kg to 5 mg), 21.4% (22 kg to 10 mg), 22.5% (24 kg to 15 mg) compared to 2.4% (2 kg)
- Percentage of patients who achieve at least 5% body weight reduction: 89% (5 mg), 96% (10 mg and 15 mg) compared to 28%
- Percentage of patients who achieve at least 20% body weight reduction (important secondary end point): 32% (5 mg, not checked for type -1 errors), 55% (10 mg), 63% (15 mg) compared to 1.3%
For the estimate of the treatment regime, Tirzepatide was associated with the following reductions in body weight in week 72 compared to placebo:
- Average reduction in body weight: 15% (5 mg), 19.5% (10 mg), 20.9% (15 mg) compared to 3.1%
- Percentage of patients who achieve at least 5% body weight reduction: 85% (5 mg), 89% (10 mg), 91% (15 mg) compared to 35%
- Percentage of patients who achieve at least 20% body weight reduction: 30% (5 mg; for type 1 error not checked), 50% (10 mg), 57% (15 mg) compared to 3.1%
The security profile of Tirzidatid resembled other incretin -based therapies that were approved for the treatment of obesity. The most frequently reported unwanted events were gastrointestinal (nausea, diarrhea, vomiting, constipation) and generally light to moderate severity.
Patients who were predicative at the beginning of the study remain included in the Surmount-1 study for another 104 weeks in order to assess the influence of Tirzepatide on body weight and the potential difference in progression on type 2 diabetes. The company will continue to evaluate the study results that are presented at an upcoming medical meeting and presented a diary assessed by experts.
“Tirepatide is the first investigation medicine that provides an average of more than 20% weight loss in a phase -3 study and increases our trust in their potential to help people with obesity,” said Jeff Emmick, MD, Vice President, Product Development, Lilly. “We are proud to explore and develop potentially innovative treatments such as Tirzatide, which helped almost two thirds of the participants in the highest dose of the highest dose when reducing their body weight at Surmount-1 by at least 20%.”
reference
Lillys Tirzatid delivered in adults with obesity or overweight of up to 22.5% in sum-1. Press release. Eli Lilly and Society. Access April 28, 2022.
This article originally appeared on MPR