ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management

What Was Tested

This registered not phased trial tested Mazdutide.

Obesity is a chronic, progressive, and relapsing disease.

It had four arms (groups): Mazdutide Placebo plus Intensive Lifestyle Intervention (experimental), Mazdutide plus Usual Lifestyle Counseling (experimental), Mazdutide plus Intensive Lifestyle Intervention (experimental) and Mazdutide Placebo plus Usual Lifestyle Counseling (experimental).

After 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide placebo once weekly plus intensive lifestyle intervention for 52 weeks during the weight maintenance period.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 420 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult men or women aged 18 years or older;. Simple obesity, defined as a body mass index (BMI) of 28.0-45.0 kg/m²;. Able and willing to provide written informed consent.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (hiv) infection, or other serious infectious or systemic diseases;; severe cardiovascular diseases, including angina pectoris, myocardial infarction, or stroke within the past 6 months;; severe gastrointestinal diseases, or a history of gastrointestinal resection surgery within the past year;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Mazdutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Mazdutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-06-10 with completion listed for 2028-12.

It ran at 13 sites in China (13).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage change of body weight (time frame: From randomization to Week 52).

It also tracked 13 secondary outcomes, for example Change in body mass index (BMI), Change in waist circumference, Change in total body fat, Change in abdominal visceral fat area, Change in hepatic fat content and Change in blood pressure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Mazdutide in 420 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, all human trials.