AI-assisted Multi-domain Lifestyle Versus Tirzepatide for Weight Loss Maintenance in Adults With Type 2 Diabetes (AIM-MAINTAIN)

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide for fat loss, obesity & body recomposition.

This is a randomized controlled trial to compare the effect of AI-assisted multi-domain lifestyle and continued tirzepatide on body weight loss maintenance.

It had two arms (groups): AI assisted multi-domain lifestyle intervention (experimental) and Tirzepatide (active comparator).

Participants will be randomized to receive multi-domain lifestyle intervention including diet, physical activity and psychological support for 52 weeks. Additionally, the weight loss maintenance program will integrate AI-assisted nutritional analysis to facilitate long-term weight management.

The registry classes the interventions as behavioral and drug.

More on the Plan

Diabetes and obesity have emerged as critical public health problems in China.

Notably, more than half of Chinese adults with diabetes are concurrently with overweight or obesity.

However, maintaining long-term weight loss remains a formidable clinical challenge.

This study aims to investigate the effect of AI-assisted multi-domain lifestyle interventions on weight loss maintenance in overweight or obese patients with type 2 diabetes, compared with tirzepatide treatment.

Who Took Part

400 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Male or female participants aged 18 to 65 years at the time of signing informed consent;. Body Mass Index (BMI) ≥27.0 kg/m²;. Type 2 diabetes mellitus diagnosed by physicians within the past 5 years prior to screening. Voluntary participation and provide written informed consent.

The full record lists 4 inclusion and 28 exclusion criteria; among the exclusions: history of type 1 diabetes mellitus or other types of diabetes, or treatment with insulin; history of obesity attributable to endocrine disorders or monogenic mutations; use of medications or products causing weight changes or affecting weight assessment within 3 months prior to the day of screening;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Tirzepatide study: the fat loss, obesity & body recomposition participants and staff both knew the treatment.

It started in 2026-04-30 with completion listed for 2028-09-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Body weight change (kg) (time frame: Change from randomization (week 20) to week 72).

It also tracked 18 secondary outcomes, for example Percent change in body weight, Body mass index, Waist and hip circumference, Body fat percentage, Skeletal muscle mass and Fat mass.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 400 people with fat loss, obesity & body recomposition.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, Fat loss, obesity & body recomposition research.