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ObesityNCT07517042

ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight Management

A study testing Mazdutide, Intensive Lifestyle Intervention and Usual Lifestyle Counseling in people with Obesity and Weight Control, run by Shanghai Zhongshan Hospital at 13 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Obesity is a chronic, progressive, and relapsing disease. Although lifestyle interventions and anti-obesity medications are effective for inducing weight loss, evidence regarding their role in long-term weight maintenance after pharmacologically induced weight reduction remains limited. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Weight Control
What is being tested?
Mazdutide, Intensive Lifestyle Intervention and Usual Lifestyle Counseling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
13 sitesChina
Study dates
10 Jun 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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.

Who cannot join

  • Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other serious infectious or systemic diseases;
  • Severe hepatic impairment (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3 times the upper limit of normal), severe renal impairment, or end-stage renal disease (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m²);
  • 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;
  • Acute or chronic pancreatitis, gallbladder disease, or pancreatic injury;
  • Obesity secondary to other causes, including Cushing's syndrome, primary hypothyroidism, hypothalamic obesity, or acromegaly; drug-induced obesity, such as obesity related to the use of antipsychotic agents or glucocorticoids;
Show all 12Show fewer
  • Current smoker or habitual smoking within the past 3 months;
  • Current use of other weight-loss medications or a history of bariatric surgery;
  • Previously diagnosed diabetes mellitus or current use of glucose-lowering medications;
  • Pregnant or breastfeeding women, or women planning pregnancy during the study period;
  • Inability to complete a 2-year follow-up due to health conditions, relocation, or other reasons;
  • Any other condition deemed by the investigator to make the participant unsuitable for participation in the study.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

JINGJING JIANG, MD, PhD contact

86-21-64041990

jiang.jingjing@zs-hospital.sh.cn

13 sites in 1 country

China13 sites, 13 recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

    Dongfang Liu, MD, 86-023-63693000, ldf023023@qq.com

    Dongfang Liu, MD

    Recruiting

  • Fujian Provincial Hospital, Affiliated to Fuzhou University

    Fuzhou, Fujian, 350000

    Gang Chen, MD, 86-0591-88216000, chengangfj@163.com

    Gang Chen, MD

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310000

    Xiaohong Wu, MD, 86-0571-85893111, drxhwu@163.com

    Xiaohong Wu, MD

    Recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

    Yong Xu, MD, 86-0830-3165233, xywyll@aliyun.com

    Yong Xu, MD

    Recruiting

  • Nanjing First Hospital, Nanjing Medical University

    Nanjing, Jiangsu, 210000

    Qian Li, MD, 86-025-52271000, qbb12345yd@163.com

    Qian Li, MD

    Recruiting

  • Huadong Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200000

    Bin Lu, PhD, 86-021-62483180, lubinfd@126.com

    Bin Lu, PhD

    Recruiting

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Jing Ma, PhD, 86-021-58752345, cherry1996@live.cn

    Jing Ma, PhD

    Recruiting

  • Shanghai Tenth People's Hospital, School of Medicine, Tongji University

    Shanghai, Shanghai Municipality, 200000

    Shen Qu, PhD, 86-021-66303680, qushencn@hotmail.com

    Shen Qu, PhD

    Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200030

    JINGJING JIANG, MD, PhD, 86-21-64041990, jiang.jingjing@zs-hospital.sh.cn

    HUIJIE ZHANG, MD, PhD

    Recruiting

  • The Affiliated Suzhou Science and Technology Town Hospital of Nanjing Medical University

    Suzhou, Jiangsu, 215000

    Zhimin Ma, MD, 86-0512-69584800, mazhimin01@sina.com

    Zhimin Ma, MD

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Hong Zhu, MD, 86-0577-55579999, zhuhong@wmn.edu.cn

    Hong Zhu, MD

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Zhe Dai, MD, 86-027-67812999, daizhewhu@outlook.com

    Zhe Dai, MD

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Xin Zheng, MD, 86-0592-2132222, zx2001528@163.com

    Changqin Liu, MD

    Recruiting

Other trials in China

About this study

Official title: Achieving Sustained Weight Control Via Exercise, Nutrition & Drugs (Mazdutide) (ASCEND- 1 Trial)

Obesity is a chronic, progressive, and relapsing disease. Although lifestyle interventions and anti-obesity medications are effective for inducing weight loss, evidence regarding their role in long-term weight maintenance after pharmacologically induced weight reduction remains limited. In addition, the high cost and potential adverse effects of weight-loss medications restrict their prolonged use, and it is unclear whether low dose medication, intensive life style intervention or together can serve as an effective strategy for weight maintenance.

This randomized controlled trial aims to evaluate the effectiveness of a 1-year intensive lifestyle intervention, a reduced dose of mazdutide (3.0 mg once weekly), or their combination in weight maintenance among individuals with obesity who have achieved initial weight loss after intensive treatment with high dose mazdutide. The study seeks to provide high-quality clinical evidence to inform long-term weight maintenance strategies after weight loss in patients with obesity.

Being tested
Mazdutide, Intensive Lifestyle Intervention, Mazdutide Placebo, Usual Lifestyle Counseling
Keywords
obesity, GLP-1 RA, Exercise, Nutrition, Sustained weight Control
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MazdutideDrug

    Mazdutide is administered subcutaneously at 3.0 mg once weekly for 52 weeks during the weight maintenance period.

  • Intensive Lifestyle InterventionBehavioural

    Participants receive a structured intensive lifestyle intervention including individualized dietary counseling, physical activity guidance, and behavioral modification support for 52 weeks during the weight maintenance period.

  • Mazdutide PlaceboDrug

    Mazdutide placebo is administered subcutaneously once weekly for 52 weeks during the weight maintenance period.

  • Usual Lifestyle CounselingBehavioural

    Participants receive general health education and non-intensive lifestyle advice on healthy eating, physical activity, and weight management for 52 weeks during the weight maintenance period.

Study groups in NCT07517042
Study groupRoleWhat they receive
Mazdutide Placebo plus Intensive Lifestyle InterventionExperimentalAfter 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.
Receives: Behavioral: Intensive Lifestyle Intervention; Drug: Mazdutide Placebo
Mazdutide plus Usual Lifestyle CounselingExperimentalAfter 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide 3.0 mg once weekly plus usual lifestyle counseling for 52 weeks during the weight maintenance period.
Receives: Drug: Mazdutide; Behavioral: Usual Lifestyle Counseling
Mazdutide plus Intensive Lifestyle InterventionExperimentalAfter 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide 3.0 mg once weekly plus intensive lifestyle intervention for 52 weeks during the weight maintenance period.
Receives: Drug: Mazdutide; Behavioral: Intensive Lifestyle Intervention
Mazdutide Placebo plus Usual Lifestyle CounselingExperimentalAfter 16-week intensive treatment with mazdutide, participants are randomized into four different arms. In this arm, participants receive mazdutide placebo once weekly plus usual lifestyle counseling for 52 weeks during the weight maintenance period.
Receives: Drug: Mazdutide Placebo; Behavioral: Usual Lifestyle Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change of body weight

    Measured: From randomization to Week 52

Secondary outcomes (13)

  1. Change in body mass index (BMI)

    Measured: From randomization to Week 52

  2. Change in waist circumference

    Measured: From randomization to Week 52

  3. Change in total body fat

    Measured: From randomization to Week 52

  4. Change in abdominal visceral fat area

    Abdominal visceral fat area is quantified by CT scan

    Measured: From randomization to Week 52

  5. Change in hepatic fat content

    Hepatic fat content is quantified by controlled attenuation parameter (CAP), measured by Fibroscan.

    Measured: From randomization to Week 52

  6. Change in blood pressure

    Measured: From randomization to Week 52

  7. Change in serum lipid profile

    Measured: From randomization to Week 52

  8. Changes in blood glucose

    Measured: From randomization to Week 52

  9. Changes in insulin sensitivity

    Insulin sensitivity is assessed by HOMA-IR index

    Measured: From randomization to Week 52

  10. Changes in pancreatic β-cell function

    Pancreatic β-cell function is assessed by HOMA-β index

    Measured: From randomization to Week 52

  11. Change in pulse wave velocity (PWV)

    Measured: From randomization to Week 52

  12. Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)

    Measured: From randomization to Week 52

  13. Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)

    Measured: From randomization to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study start10 Jun 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07517042
Sponsor's protocol ID
B2025-712
Status last verified
Dec 2025
First submitted
18 Mar 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication.

Questions about this trial

What is this clinical trial studying?

A study testing Mazdutide, Intensive Lifestyle Intervention and Usual Lifestyle Counseling in people with Obesity and Weight Control, run by Shanghai Zhongshan Hospital at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JINGJING JIANG, MD, PhD (86-21-64041990, jiang.jingjing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change of body weight (time frame: From randomization to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07517042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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