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Trial · Interventional

RecruitingPhase 3Registry data

A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

Short name ATTAIN-NOW

NCTNCT07794579 (opens ClinicalTrials.gov in a new tab)Other id27823Other idJ2A-MC-GZVAOther id2026-526175-35-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
2,001 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
12 countries

United States, Argentina, China, Czechia, Germany, India, Japan, Mexico, Puerto Rico, South Korea, Spain, Taiwan

Start
26 Aug 2026
Primary completion
Aug 2029 (estimated)
Completion
Sept 2030 (estimated)
First posted
31 Aug 2026
Last update posted
8 Oct 2026
Conditions
Overweight · Prediabetic State · Prehypertension · Obesity, Abdominal

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028202920302031
  1. Ph 3

    ATTAIN-NOW

    NCT07794579

    26 Aug 2026 to est. Sept 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will evaluate the efficacy and safety of orforglipron in participants with overweight and assess whether it helps reduce the future risk of obesity-related conditions, including type 2 diabetes, hypertension, and dyslipidemia, and progression to class 1 obesity.

Interventions

  • OrforglipronDrug
  • PlaceboDrug

Arms3

  • Experimental

    Orforglipron

    Participants will receive orforglipron orally

  • Experimental

    Orforglipron to Placebo

    Participants will receive orforglipron orally followed by placebo orally

  • Experimental

    Placebo to Orforglipron

    Participants will receive placebo orally followed by orforglipron orally

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to Onset of Obesity Related Complications or Class 1 Obesity

    Time frame · Baseline to Week 104

    Registry description

    Obesity related complications defined as type 2 diabetes, hypertension, or dyslipidemia; Class 1 obesity defined as body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or an equivalent region-specific threshold

Secondary outcomes(12)

  1. Percent Change from Baseline in Body Weight

    Time frame · Baseline, Week 104

  2. Time to Onset of Waist-to-Height Ratio ≥0.6

    Time frame · Baseline to Week 104

  3. Change from Baseline in Waist Circumference

    Time frame · Baseline, Week 104

  4. Time to Onset of Class 1 Obesity

    Time frame · Baseline to Week 104

  5. Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia

    Time frame · Baseline to Week 104

  6. Time to Onset of Type 2 Diabetes

    Time frame · Baseline to Week 104

  7. Percent Change from Baseline in Total Fat Mass

    Time frame · Baseline, Week 104

  8. Change from Baseline in Systolic Blood Pressure

    Time frame · Baseline, Week 104

  9. Change from Baseline in Glycated Hemoglobin (HbA1c)

    Time frame · Baseline, Week 104

  10. Percent Change from Baseline in Triglycerides

    Time frame · Baseline, Week 104

  11. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score

    Time frame · Baseline, Week 104

  12. Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron

    Time frame · Week 4, 12, 24, 52, and 76

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have an increased waist-to-height ratio of ≥0.5 * Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia) * Have at least one unsuccessful attempt to reduce body weight based on diet and exercise * Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds Exclusion Criteria: * Have type 1 diabetes, type 2 diabetes, or any other type of diabetes * Do not have a stable body weight within 90 days before screening * Have a documented obesity diagnosis or self-reported history of BMI ≥30 kg/m² (or an equivalent region-specific threshold) * Have taken medications for weight loss, including over-the counter medications or alternative therapies, within 180 days prior to screening * Have a prior or planned surgical treatment or procedure for obesity * Have hypertension or history of hypertension * Have dyslipidemia or history of dyslipidemia

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