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Completed

NCT Number: NCT06584916

A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)

The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction in participants who previously completed treatment with injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy) in the SURMOUNT-5 trial (NCT05822830).

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Puerto Rico Medical Research, Ponce, Puerto Rico

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About this study

All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. SURMOUNT-5 randomized participants to either injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy); therefore, all ATTAIN-MAINTAIN participants had prior exposure to one of these injectable incretin-based therapies before transitioning directly to orforglipron 12 mg capsule or placebo. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have completed the SURMOUNT-5 study (NCT05822830; a trial of injectable tirzepatide [Zepbound] versus injectable semaglutide [Wegovy]) on study treatment

Exclusion criteria

  • Have Type 1 Diabetes, Type 2 Diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
  • Have a prior or planned surgical treatment for obesity
  • Have acute or chronic hepatitis
  • Have a history of acute or chronic pancreatitis

Treatment and study plan

Orforglipron

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5

    Time frame: Week 52

Secondary outcomes

  1. Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment

    Time frame: Week 52

  2. Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5

    Time frame: Week 52

  3. Change from Baseline in Body Weight

    Time frame: Baseline, Week 52

  4. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 52

  5. Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Orforglipron Once Daily Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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