- Paper
- Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity: A Phase 2 Trial (New England Journal of Medicine, 2025)
- Study type
- Randomized, double-blind, placebo-controlled, dose-ranging Phase 2 trial in 592 adults (NCT05669599). Funded by Amgen.
- What was tested
- Injections under the skin, mostly every 4 weeks, with one group every 8 weeks, versus placebo, for 52 weeks. Two cohorts: people with obesity without type 2 diabetes, and people with obesity and type 2 diabetes.
- Main findings
- Average weight change at week 52 ranged from -12.3% to -16.2% across MariTide groups versus -2.5% on placebo without diabetes, and -8.4% to -12.3% versus -1.7% with type 2 diabetes. Gut side effects were common.
- Limitations
- Mid-stage trial, one year long, sponsor-funded. The abstract reports a range across groups and does not single out the every-8-week group.
- Does not prove
- That MariTide works or is safe long term, that longer gaps between injections keep weight off, or that it beats any approved medicine.
Research Reviews
Monthly Weight-Loss Injections? What MariTide Trials Are Testing
The short answer
As of September 15, 2026, less frequent MariTide injections are a trial schedule, not a treatment option. MariTide is not approved by the FDA. A published Phase 2 trial tested mainly monthly injections. Gaps of 8 or 12 weeks are now being tested in Phase 3 studies, mostly for keeping weight off. None of those has reported results.
Editor's note: First published. Trial statuses checked against ClinicalTrials.gov and Amgen's August 4, 2026 results release.

A weight-loss injection once a month, or even four times a year, sounds like a big change from the weekly shots people know today. MariTide is the drug behind most of that talk. This article looks at what the trials are really testing, and what has actually been shown so far.
What MariTide is, in plain language
MariTide is the name Amgen uses for maridebart cafraglutide, its experimental obesity drug. Its old lab code is AMG 133. All three names mean the same molecule. For the background on how it works, see our MariTide profile.
Amgen describes it as an antibody-peptide conjugate that switches on the GLP-1 receptor and blocks the GIP receptor. The published Phase 2 paper uses the mirror wording, a peptide-antibody conjugate. The Phase 1 paper explains the build: an antibody that blocks the GIP receptor, joined to two GLP-1-like peptides by short linkers.
- GLP-1 is a gut hormone signal linked to fullness. Drugs like semaglutide switch it on. Our GLP-1 explainer covers the basics.
- GIP is another gut hormone signal. Tirzepatide switches it on. MariTide does the opposite and blocks it.
- The antibody part matters for timing. Antibodies stay in the body far longer than small peptides. In the Phase 1 study, the average half-life was about 21 days, which the authors said made every-4-week dosing possible.
Current status, checked September 15, 2026: MariTide is investigational. It is not in the FDA's Drugs@FDA database, and Amgen's own August 4, 2026 results release still lists its obesity studies as ongoing Phase 3 trials. It is not a medicine you can be prescribed.
Starting treatment vs keeping weight off
Trials ask two different questions, and they are easy to mix up.
- Starting treatment. People begin the drug and researchers measure how much weight they lose compared with placebo, a dummy injection. The Phase 2 trial and the main MARITIME-1 and MARITIME-2 Phase 3 trials are built this way.
- Maintaining a result. People have already lost weight, either on MariTide or on another drug. Researchers then test whether a lighter schedule, such as fewer injections, keeps the weight off. The extension trials and the MARITIME-SWITCH trial are built this way.
Most of the talk about injections every 8 or 12 weeks is about the second question. A schedule that holds weight steady after loss is not the same as a schedule that causes the loss in the first place. The trials treat them separately, so this article does too.
The trials, side by side
This table covers every MariTide study where the injection schedule is part of the question, plus the main Phase 3 trials. It lists how often injections were given, never how much. Status comes from ClinicalTrials.gov, checked September 15, 2026.
| Trial (NCT) | Population | Comparator | Dosing frequency studied | Duration | Main endpoints | Status and results | Source |
|---|---|---|---|---|---|---|---|
| Phase 1 (NCT04478708) | 110 adults with obesity | Placebo | A single injection, or 3 injections given every 4 weeks | About 5 to 7 months of follow-up | Side effects (primary); weight and blood markers | Completed. Published 2024: dose-dependent weight loss. In the repeat-injection groups, weight loss lasted up to 150 days after the last injection. | Nature Metabolism, PMID 38316982 |
| Phase 2, Part 1 (NCT05669599) | 592 adults: 465 with obesity without type 2 diabetes, 127 with obesity and type 2 diabetes | Placebo | Every 4 weeks in most groups; one group every 8 weeks (no-diabetes cohort only) | 52 weeks | Percent change in body weight at week 52 | Completed. Published 2025. Weight change -12.3% to -16.2% vs -2.5% placebo (no diabetes); -8.4% to -12.3% vs -1.7% (with diabetes). Gut side effects common. | NEJM, PMID 40549887 |
| Phase 2, Part 2 (NCT05669599) | Part 1 participants who met entry criteria, re-randomized | Placebo | Monthly, or every 12 weeks (per Amgen's design description) | A further 52 weeks | Keeping weight off in year two | Sponsor-reported only (Feb 2026): most kept their weight loss on monthly or every-12-week injections, with low nausea and vomiting. No peer-reviewed numbers found. | Amgen release, Feb 3, 2026 |
| Phase 2, type 2 diabetes (NCT06660173) | 409 adults with type 2 diabetes, BMI 23 to 50 | Placebo | Monthly (per Amgen; the registry does not state the interval) | 24 weeks, with optional exploratory 24-week extensions | Change in HbA1c (average blood sugar) at week 24 | Active, not recruiting. Sponsor-reported only (Feb 2026): meaningful drops in HbA1c and weight. No publication found. | ClinicalTrials.gov; Amgen release |
| MARITIME-1, Phase 3 (NCT06858839) | 3,853 adults with obesity, or overweight plus a weight-related condition, without diabetes | Placebo | Three dose levels; the registry does not state the interval | 72 weeks | Percent change in body weight at week 72 | Active, not recruiting. No results. Primary completion estimated January 2027. | ClinicalTrials.gov |
| MARITIME-2, Phase 3 (NCT06858878) | 1,105 adults with type 2 diabetes and obesity or overweight | Placebo | Three dose levels; the registry does not state the interval | 72 weeks | Percent change in body weight at week 72 | Active, not recruiting. No results. Primary completion estimated January 2027. | ClinicalTrials.gov |
| MARITIME-1 EXTENSION, Phase 3 (NCT07684235) | About 3,200 people who completed 72 weeks of MARITIME-1 (estimated) | Placebo (every 4 weeks) | Every 4, every 8, or every 12 weeks | 48 weeks for the main weight endpoint; safety up to 60 weeks | Weight change from the start of the parent trial; side effects | Recruiting since July 2026. No results. Primary completion estimated December 2027. | ClinicalTrials.gov |
| MARITIME-2 EXTENSION, Phase 3 (NCT07684144) | About 950 people who completed MARITIME-2 (estimated) | Placebo (every 4 weeks) | Every 4 or every 8 weeks | 48 weeks for the main weight endpoint; safety up to 60 weeks | Weight change from the start of the parent trial; side effects | Recruiting since July 2026. No results. Primary completion estimated December 2027. | ClinicalTrials.gov |
| MARITIME-SWITCH, Phase 3 (NCT07575399) | About 300 adults without diabetes who lost at least 10% of body weight on a weekly GLP-1 drug and are stable on it | No placebo: two MariTide schedules compared | Registry: "dosing schedule 1" and "dosing schedule 2". Amgen: every 8 weeks or quarterly | 68 weeks for the main endpoint; safety up to 84 weeks | Percent weight change at week 68; share keeping at least 80% of earlier weight loss; side effects | Recruiting since May 2026. No results. Primary completion estimated January 2028. | ClinicalTrials.gov; Amgen release, Aug 4, 2026 |
Other Phase 3 trials test MariTide against placebo for heart and blood vessel events (MARITIME-CV, NCT07037433), heart failure (MARITIME-HF, NCT07037459), sleep apnea (MARITIME-OSA-1, NCT07225686, and MARITIME-OSA-2, NCT07226765), and obesity in Japan (MARITIME-3-J, NCT06987695). A Phase 2b trial in people with raised liver fat (NCT07441252) gives injections every 4 weeks for 52 weeks. None of these has reported results.
What "monthly", "every 8 weeks" and "quarterly" mean in these studies
The words sound like calendar terms. In the trial records they are fixed week counts.
- "Monthly" means every 4 weeks. The registries write it as Q4W. That works out to about 13 injections a year, not 12.
- Every 8 weeks (Q8W) is about 6 or 7 injections a year. In Phase 2 it was one of the starting schedules. In the extension trials and MARITIME-SWITCH it is a maintenance schedule.
- "Quarterly" means every 12 weeks (Q12W), about 4 or 5 injections a year. It appears only in maintenance settings: Phase 2 Part 2, the MARITIME-1 extension, and, per Amgen, MARITIME-SWITCH.
Amgen's August 2026 release says the drug's long-acting design "supports starting with monthly dosing" and staying on it with "as few as 4 or 6 doses per year". That is the company's goal for the program. It is not yet a finding from a completed Phase 3 trial.
The switch study is worth reading closely. People in it lost weight on a weekly GLP-1 drug first. The question is whether moving to less frequent MariTide holds that loss. It does not test whether MariTide on its own causes that much weight loss, and it has no placebo group.
What the published results show, and what they don't
The one peer-reviewed efficacy result is Phase 2 Part 1. Across the MariTide groups, people without diabetes lost an average of 12.3% to 16.2% of body weight at 52 weeks, against 2.5% on placebo. People with type 2 diabetes lost 8.4% to 12.3%, against 1.7%. Their HbA1c fell by 1.2 to 1.6 percentage points, against a change of 0.1 points on placebo.
Those figures come from the journal's main analysis, which counts everyone who was randomized, including people who stopped treatment. Amgen's press releases have quoted higher "up to about 20%" figures. Those use a different way of analysing the same data, so the two sets of numbers are not in conflict, but they are not interchangeable either.
Side effects. Gut side effects such as nausea and vomiting were common. The paper says they were less frequent when treatment began at a lower level and was increased step by step. The authors reported no unexpected safety signals. A one-year trial of a few hundred people cannot rule out rarer problems.
The every-8-week starting group. It was part of Phase 2, but the published abstract reports a range across all groups and does not give a separate figure for that group. We have not reported one here.
Year two. Amgen says most Phase 2 participants kept their weight off for another 52 weeks on monthly or every-12-week injections, with very low rates of nausea and vomiting. That is a company statement from February 2026. We found no journal paper or posted registry results with the numbers behind it.
What is still unknown
- Durability. No Phase 3 trial has shown whether injections every 8 or 12 weeks keep weight off. The extension trials are not expected to reach their main endpoint before late 2027, and MARITIME-SWITCH before early 2028, per registry estimates.
- Tolerability after a switch. Moving from a weekly drug to a long-acting one is a new situation. MARITIME-SWITCH tracks side effects for up to 84 weeks, but nothing has reported.
- How many people qualify. The maintenance trials only enroll people who already lost weight and finished earlier treatment. Results, when they come, will describe that group, not everyone starting out.
- Cross-trial comparisons. It is tempting to line MariTide's numbers up against semaglutide or tirzepatide. Different trials enroll different people, run for different lengths, and use different analyses. Only a head-to-head trial can answer which works better, and none has been done.
- Registry details. The MARITIME-SWITCH record calls the trial open-label in its full title, yet lists participants and investigators as masked. The two schedules are not named in the registry. We rely on Amgen's description for the every-8-week and quarterly wording.
- Long-term safety. Large outcome trials in heart disease and heart failure are running, with primary completion estimated for mid-2028.
What the evidence supports
- A published Phase 2 trial found substantial weight loss versus placebo at 52 weeks, mostly with injections every 4 weeks
- Phase 3 trials are testing maintenance with injections every 8 or 12 weeks
- Amgen reports that most Phase 2 participants kept weight off in year two on monthly or every-12-week injections (not yet peer-reviewed)
What it does not support
- That quarterly injections are an available treatment; MariTide is not approved
- That less frequent injections keep weight off long term; no Phase 3 result exists
- That switching from a weekly GLP-1 drug to MariTide works; MARITIME-SWITCH is still recruiting
- That MariTide beats semaglutide or tirzepatide; there is no head-to-head trial
What this does not mean
- This does not mean you can get MariTide on a monthly or quarterly schedule. It is not approved, and it exists legitimately only inside clinical trials.
- This does not mean longer gaps between injections are proven to work. The trials testing that have not reported.
- This does not mean a company announcement is the same as trial evidence. Phase 2 Part 2 numbers have not been published.
- This does not mean you should stop or change a weekly medicine you already take. Talk to the doctor who prescribed it.
- This is general education, not medical advice.
Frequently asked questions
Is MariTide a once-a-month injection?
In trials, yes. The published Phase 2 trial gave MariTide mostly every 4 weeks, which trial records call monthly, and reported substantial weight loss versus placebo at 52 weeks. But MariTide is not approved by the FDA as of September 15, 2026, so a monthly MariTide injection is a trial schedule, not a treatment you can be prescribed.
Can MariTide be taken every 3 months?
Only inside trials so far. An every-12-week schedule was used for maintenance in Phase 2 Part 2, and Amgen says most people kept weight off, but those numbers are not published. The MARITIME-1 extension and MARITIME-SWITCH Phase 3 trials are testing it now. None has reported results.
What is the MARITIME-SWITCH trial?
A Phase 3 trial (NCT07575399) in about 300 adults who already lost at least 10% of their weight on a weekly GLP-1 drug. They move to MariTide on one of two schedules, which Amgen describes as every 8 weeks or quarterly. The main question is weight change at week 68. It started recruiting in May 2026 and has no results.
When will MariTide Phase 3 results come out?
The registry estimates primary completion for MARITIME-1 and MARITIME-2 in January 2027, and for the extension trials in December 2027. Those are estimated completion dates, not promised publication dates. Results and any approval decision would come later, and dates in registries often move.
Editorial noteEditorial research check on 2026-09-15 against registry records, the published Phase 1 and Phase 2 papers, and Amgen releases. Not reviewed by a medical professional. No doses, no how-to. Written and maintained by The Peptide Skin Science Editorial Team. See our research review process.
Sources & further reading
- Amgen Reports Second Quarter 2026 Financial Results (sponsor-reported pipeline update) · Amgen, 2026
- Amgen Reports Fourth Quarter and Full Year 2025 Financial Results (sponsor-reported Phase 2 Part 2 and Phase 2 type 2 diabetes topline) · Amgen, 2026
- Results From Amgen's Phase 2 Obesity Study of Monthly MariTide Presented at the American Diabetes Association 85th Scientific Sessions (Part 2 design description) · Amgen, 2025
- Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity: A Phase 2 Trial. · New England Journal of Medicine, via PubMed, 2025
- A GIPR antagonist conjugated to GLP-1 analogues promotes weight loss with improved metabolic parameters in preclinical and phase 1 settings. · Nature Metabolism, via PubMed, 2024
- Phase 1 single and multiple ascending dose study of AMG 133 in participants with obesity · ClinicalTrials.gov (U.S. National Library of Medicine)
- Phase 2 dose-ranging study of AMG 133 in adults with overweight or obesity, with or without type 2 diabetes · ClinicalTrials.gov (U.S. National Library of Medicine)
- Phase 2 study of maridebart cafraglutide in adults with type 2 diabetes · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-1: Phase 3 study in adults with obesity or overweight without type 2 diabetes · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-2: Phase 3 study in adults with type 2 diabetes and obesity or overweight · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-1-EXTENSION: Phase 3 long-term extension trial · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-2-EXTENSION: Phase 3 long-term extension trial in type 2 diabetes · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-SWITCH: Phase 3 trial of switching from GLP-1 receptor agonists to maridebart cafraglutide · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-CV: Phase 3 cardiovascular outcomes trial · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-HF: Phase 3 heart failure trial · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-OSA-1: Phase 3 sleep apnea trial (on PAP therapy) · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-OSA-2: Phase 3 sleep apnea trial (not on PAP therapy) · ClinicalTrials.gov (U.S. National Library of Medicine)
- MARITIME-3-J: Phase 3 obesity trial in Japan · ClinicalTrials.gov (U.S. National Library of Medicine)
- Phase 2b trial in adults with elevated liver fat and obesity or overweight · ClinicalTrials.gov (U.S. National Library of Medicine)
- Drugs@FDA database (openFDA drugsfda endpoint searched for maridebart and MariTide: no records) · U.S. Food & Drug Administration
Where a specific study is named, we link it directly. General references indicate the body of literature a claim draws on. See our source policy.
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